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Adverse Event Report

COLLAGEN CORP. ZYDERM 1 COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT   back to search results
Catalog Number 5021, 5022, 5177
Event Date 01/16/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reported a pt who was treated with two formulations of collagen on 12/10/97 in the infraorbital area, nasolabial folds and upper and lower vermilion border. The patient had an office visit on 1/16/98; she had erythematous nodules at the infraorbital and nasolabial fold treatment sites. The chart did not indicate when the pt developed symptoms. The physician believed the pt had a hypersensitivity to collagen and did not plan to treat her with collagen again. He prescribed topical vitamin k and arnica cream to apply to the erythematous nodules and oral pycnogenol.

 
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Brand NameZYDERM 1 COLLAGEN IMPLANT
Type of DeviceINJECTABLE COLLAGEN IMPLANT
Baseline Brand NameZYDERM 1 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 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 Key149653
MDR Report Key153620
Event Key144261
Report Number2939859-1998-00060
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/04/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/1998
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 Number97C151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/1998
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: 02/26/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE,

Database last updated on January 30, 2009

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