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Adverse Event Report

COLLAGEN CORP. ZYPLAST COLLAGEN IMPLANT GAX   back to search results
Catalog Number 5025, 5029, 5161, 5163, 5164
Event Date 06/17/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reported a pt who was treated with two formulations of collagen in the glabella and nasolabial folds on 5/27/97. On approx. 6/17/97, the pt developed urticarial plaques in the glabellar area, which later resolved. On 8/7/97, the pt was seen with a cyst in the glabellar region, date of onset unk. The physician did not believe the cyst was related to collagen, but attributed it to the pt's acne history and prescribed an interlesional injection of aristocort suspension. On 8/13/97, the cyst had not resolved, so it was injected again. A consulting physician examined the pt on 8/26/97 and noted urticarial plaques in the nasolabial folds. The pt was diagnosed with a hypersensitivity to collagen and was prescribed intramuscular kenalog and zyrtec 10mg twice daily by mouth.

 
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Brand NameZYPLAST COLLAGEN IMPLANT
Type of DeviceGAX
Baseline Brand NameZYPLAST COLLAGEN IMPLANT
Baseline Generic NameGAX
Baseline Catalogue Number5025, 5029, 5161, 5163, 5164
Baseline Device 510(K) Number
Baseline Device PMA Number
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
Device Event Key119846
MDR Report Key122368
Event Key115050
Report Number2939859-1997-00201
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Health Professional,Consumer
Reporter Occupation Physician
Type of Report Initial
Report Date 08/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5025, 5029, 5161, 5163, 5164
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/26/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/23/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ANAPROX (UNK TO UNK),

Database last updated on December 31, 2008

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