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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAST BIOSURGERY SURGIWRAP SURGICAL MESH

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MAST BIOSURGERY SURGIWRAP SURGICAL MESH Back to Search Results
Catalog Number 27202-05
Event Date 02/01/2010
Event Type  Injury  
Event Description

A patient had a piece of surgiwrap implanted in (b) (6) 2009 during a laparoscopic oophorectomy. In (b) (6) 2010, she returned complaining of pain. She was brought back into surgery where a severe tissue reaction was found and the surgiwrap sheet was found to be a "hardened mass". The surgeon removed the hardened surgiwrap and upon removal, the patient's pain absolved.

 
Manufacturer Narrative

Since there is no product available for evaluation, the investigation of this complaint is limited and the company is unable to draw a conclusion.

 
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Brand NameSURGIWRAP
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
MAST BIOSURGERY
san diego CA
Manufacturer Contact
nicole deboer
6749 top gun st
ste 108
san diego , CA 92121
8585508050
MDR Report Key1674854
Report Number3004661493-2010-00002
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type User facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number27202-05
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/30/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/29/2010 Patient Sequence Number: 1
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