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Adverse Event Report

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

Circumcision clamp was placed on foreskin, the foreskin slipped out of the clamp before hemostasis had occurred in the foreskin. All clamped areas were in proper position. Multiple 4. 0 chromic sutures were placed in the foreskin and foreskin was re-inspected. Gauze re-wrapped no bleeding (as described by the physician).

 
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Brand NameCIRCUMCISION 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)
ALLEGIANCE V. MUELLER
1500 waukegan rd
mcgaw park IL 60085
Device Event Key46960
MDR Report Key46111
Event Key43220
Report Number46111
Device Sequence Number1
Product CodeHFX
Report Source Distributor
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 Received11/01/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device MODEL 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? Yes
Date Report Sent to FDA11/01/1996
Distributor Facility Aware Date10/24/1996
Event Location Hospital
Date Report TO Manufacturer11/01/1996
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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