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Adverse Event Report

COLLAGEN CORP. COLLAGEN TEST IMPLANT   back to search results
Catalog Number 5026
Event Date 06/01/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reports that a pt was skin tested in 3/97 (exact date unknown) in the forearm. The pt immediately noticed a palpable lump at the skin test site. In 6/97 (exact date unknown), the skin test site enlarged and became erythematous. On 7/8/97, the pt returned to the physician's office presenting with an erythematous nodule "the size of a grape" at the skin test site. The physician diagnosed a positive skin test and an abscess. On 7/11/97, the physician attempted to aspirate the nodule unsuccessfully with a 16-gauge needle. A course of oral keflex was prescribed.

 
Manufacturer Narrative

The physician reported that after the incision and drainage was performed on 11 july 1997, the symptoms resolved. As of 6 january 1999, there had been no further symptoms.

 
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Brand NameCOLLAGEN TEST IMPLANT
Type of DeviceCOLLAGEN TEST IMPLANT
Baseline Brand NameZYDERM I COLLAGEN IMPLANT (35 MG/ML)
Baseline Generic NameCOLLAGEN IMPLANT
Baseline Catalogue NumberNA
Baseline Model Number5026
Baseline Device FamilyZYDERM/ZYPLAST
Baseline Device 510(K) Number
Baseline Device PMA NumberP800022
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed07/23/1981
Manufacturer (Section F)
COLLAGEN CORP.
2500 faber place
palo alto CA 94303
Manufacturer (Section D)
COLLAGEN CORP.
2500 faber place
palo alto CA 94303
Manufacturer (Section G)
ALLERGAN
48490 milmont dr.
fremont CA 94538
Manufacturer Contact
ross erickson
2500 faber place
palo alto , CA 94303
(415) 354 -3905
Device Event Key110081
MDR Report Key112117
Event Key105415
Report Number2939859-1997-00175
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/08/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/31/1999
Device Catalogue Number5026
Device LOT Number96D086G
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/08/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/1996
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: 02/08/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ESTROGENS, CONJUGATED (UNK TO 7/8/97),07/08/1997

Database last updated on January 30, 2009

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