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Adverse Event Report

COLLAGEN CORPORATION ZYDERM 1 COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT   back to search results
Catalog Number 5021,5022,5177
Event Date 12/08/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reported a pt who was skin tested in 10/1997; the test result was negative. She received her first treatment in the periorbital area and the nasolabial folds on 11/20/1997. She returned to the physician's office on 12/8/1997 with swelling and induration in the nasolabial folds and periorbital area she described as being intermittent and painful. The physician did not believe the sites were infected and believed the pt may have developed a hypersensitivity. The pt returned on 12/16/1997 and was still concerned about her symptoms of swelling, induration, and pain, so the physician gave her cipro samples to take for a 7 day course. He still did not believe the symptoms were an infection. The medication did not seem to improve her symptoms as of 12/23/1997, and he believed her symptoms were definitely a hypersensitivity to collagen since the antibiotic had no effect. The physician planned no further intervention for the symptoms.

 
Manufacturer Narrative

The symptoms resolved on 20 december 1997 according to the physician.

 
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Brand NameZYDERM 1 COLLAGEN IMPLANT
Type of DeviceINJECTABLE COLLAGEN IMPLANT
Baseline Brand NameZYDERM COLLAGEN IMPLANT
Baseline Generic NameINJECTABLE COLLAGEN IMPLANT
Baseline Catalogue Number5021,5022,5177
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COLLAGEN CORPORATION
2500 faber place
palo alto CA 94303
Manufacturer (Section D)
COLLAGEN CORPORATION
2500 faber place
palo alto CA 94303
Manufacturer (Section G)
COLLAGEN CORPORATION
48490 milmont dr.
fremont CA 94538
Manufacturer Contact
denise gottfried
2500 faber place
palo alto , CA 94303
(650) 354 -4918
Device Event Key141163
MDR Report Key144780
Event Key135962
Report Number2939859-1998-00010
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/23/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date02/29/2000
Device Catalogue Number5021,5022,5177
Device LOT Number97C151F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/23/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/1997
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: 08/27/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
1 XANAX (UNK TO 12/23/1997) 12/23/1997
2 SALINE BREAST IMPLANT (S) (TO 12/23/1997) 12/23/1997

Database last updated on January 30, 2009

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