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Adverse Event Report

ALLEGIENCE V MUELLER CIRCUMCISION CLAMP   back to search results
Catalog Number HS8609
Event Date 10/19/1996
Patient Outcome  Required Intervention;
Event Description

Clamp placed on foreskin slipped out of clamp. All clamp areas in proper position. Multiple 4. 0 chromic sutures placed and foreskin re-inspected. Gauze re-wrapped. No bleeding. (as described by the physician).

 
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Brand NameCIRCUMCISION CLAMP
Type of DeviceCIRCUMCISION CLAMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLEGIENCE V MUELLER
1500 waukegan rd
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIENCE V MUELLER
1500 waukegan rd
mcgaw park IL 60085
Device Event Key46960
MDR Report Key71816
Event Key43220
Report Number71816
Device Sequence Number1
Product CodeHFX
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/24/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHS8609
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/1996
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/21/1996
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer10/24/1996
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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