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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICOUNT SURGICOUNT LAP SPONGE SPONGE - LAP

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SURGICOUNT SURGICOUNT LAP SPONGE SPONGE - LAP Back to Search Results
Catalog Number SM1818PS
Event Date 11/08/2011
Event Type  Malfunction  
Event Description

When counting out surgicount lap sponges, it was noted lose free strings falling off of sponge which could be retained in the patient. The item was removed from the field and all sponges were inspected. ======================manufacturer response for sponge - lap, surgicount lap sponge (per site reporter). ======================awaiting response.

 
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Brand NameSURGICOUNT LAP SPONGE
Type of DeviceSPONGE - LAP
Manufacturer (Section D)
SURGICOUNT
2 venture plaza
suite 350
irvine CA 92618
MDR Report Key2362314
Report Number2362314
Device Sequence Number1
Product CodeLWH
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/29/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue NumberSM1818PS
Device LOT Number7877
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2011
Device Age0 dy
Event Location HOSPITAL

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