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Adverse Event Report

COLLAGEN CORP COLLAGEN TEST IMPLANT   back to search results
Catalog Number 5026
Event Date 02/27/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician reported a patient who was skin tested in the forearm with negative results on 17 february 1999. On 27 february 1999, the patient developed facial and neck edema, facial hyperemia, and parathesias of the arms and legs. On 27 february 1999, the physician prescribed intramuscular urbason. The symptoms resolved on 02/march 1999. The physician considered the symptoms product related.

 
Manufacturer Narrative

Device evaluation summary below: re: complaint investigation - systemic problems - edema face, erythema, and paresthesia. Lot #97d011. Co reviewed the device history records for this lot from finished product packaging to the hide batch. All sterility, bioburden, pyrogen (rabbit) and limulus amebocyte lysate 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 nor 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. Note: the use of collagen test implant and/or any collagen implant are contraindicated in patients with a history of anaphylactic reactions or severe allergies. Director, global quality assurance.

 
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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 Key209972
MDR Report Key216466
Event Key203122
Report Number2939859-1999-00076
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/01/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/31/2000
Device Catalogue Number5026
Device LOT Number97D011
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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