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Adverse Event Report

COLLAGEN CORP. ZYDERM 2 COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT   back to search results
Catalog Number 0916, 0917
Event Date 03/29/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This is the same event and the same pt reported under mdr id# 2939859-1999-103. This is the first mdr submitted for the first suspect product. A physician reported a pt who was treated on 29 march 1999 in the nasolabial folds, oral commissures, and upper and lower vermilion boreders with two formulations of product. There was no sudden blanching or dramatic color change noted at time of treatment. Within 8 hours, the right upper oral commissure treatment site became "purple" and the same night the area became painful. On 30 march 1999, the area was brusied and painful and the pt self-medicated with advil "around the clock. " on 31 march 1999, the blueness extended from the treatment site up to the nose and down to the jaw line and remained painful. The physician prescribed nitroglycerine and temovate creams, and oral duricef. On 1 april 1999, the area was slightly swollen, painful, and the pt had difficulty eating/laughing. The physician prescribed valtrex prophalactically, and prescribed hydrogen peroxide to clean the area. On 4 april 1999, the right oral commissure area was pink and the "blueness" had resolved. On 6 april 1999, the area was improved. On 8 april 1999, a "red and raw", dime-size area was beginning to slough; in the middle was a "hole" the size of the tip of a q-tip and which was forming a scab. The area surrounding the "red raw" area was pink and approximately 1/2 dollar in size. On 12 april 1999, the scab had resolved and there was a small "pin-point" open area with yellow colored drainage. The physician believed the symptoms were related to a necrosis.

 
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Brand NameZYDERM 2 COLLAGEN IMPLANT
Type of DeviceINJECTABLE COLLAGEN IMPLANT
Baseline Brand NameZYDERM 2 COLLAGEN IMPLANT
Baseline Generic NameINJECTABLE COLLAGEN IMPLANT
Baseline Catalogue Number0916, 0917
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COLLAGEN CORP.
2500 faber pl.
palo alto CA 94303
Manufacturer (Section D)
COLLAGEN CORP.
2500 faber pl.
palo alto CA 94303
Manufacturer (Section G)
COLLAGEN CORPORATION
48490 milmont drive
fremont CA 94538
Manufacturer Contact
tim kirkelie
700 ward dr
santa barbara , CA 93111
(800) 624 -4261 ext 4305
Device Event Key214969
MDR Report Key221672
Event Key207998
Report Number2939859-1999-00102
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/07/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2001
Device Catalogue Number0916, 0917
Device LOT Number98L021H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/13/2000 Patient Sequence Number: 1
#TreatmentTreatment Date
1 PREMPRO (UNK TO 04/08/1999). 04/08/1999

Database last updated on January 30, 2009

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