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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 01/01/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reported a pt who was treated in the nasolabial furrows in 1/1998. A few hours after the treatment, the pt developed edema, erythema, and hardness in the nasolabial furrows. In 1/1998, the physician presecribed oral corticosteroids and topical gentelin beta, both of which were effective. The physician believed the symptoms were probably product related.

 
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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 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 Key154521
MDR Report Key158640
Event Key149068
Report Number2939859-1998-00093
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/26/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5021,5022,5177
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/26/1998
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: 03/23/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE,

Database last updated on February 28, 2009

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