FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

COLLAGEN CORP. ZYDERM FL COLLAGEN IMPLANT INJECTABLE COLLAGEN IMPLANT   back to search results
Catalog Number 5094, 5095
Event Date 07/01/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reported a pt who rec'd her third treatment in 07/1998 in the periocular region. Fifteen days later, the pt developed nodules at the implant sites without itching or erythema. The physician excluded hypercorrection. In the physician's opinion, a sensitization to collagen may possibly have occurred. The physician prescribed oral corticosteroids, which were ineffective.

 
Manufacturer Narrative

Device eval summary below: re: complaint investigation - hypersensitivity at injection site. Co reviewed the device history records for these lot from the finished product packing to the hide batch. All sterility, bioburden, pyrogen(rabbit) and lal testing was performed as required and all tests passed. During review of the device history records, several minor deviations were noted. None of the deviations noted were significant or would contribute to a cause for this complaint. Based on the review of the device history records. Co finds no assignable cause for this complaint.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameZYDERM FL COLLAGEN IMPLANT
Type of DeviceINJECTABLE COLLAGEN IMPLANT
Baseline Brand NameZYDERM FL COLLAGEN IMPLANT
Baseline Generic NameINJECTABLE COLLAGEN IMPLANT
Baseline Catalogue Number5094, 5095
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 Key187808
MDR Report Key193287
Event Key181697
Report Number2939859-1998-00254
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/07/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/1998
Device Catalogue Number5094, 5095
Device LOT Number96L219
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/07/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1996
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH