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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL SURGIPRO MESH

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COVIDIEN, FORMERLY US SURGICAL SURGIPRO MESH Back to Search Results
Event Date 04/23/2012
Event Type  Injury  
Event Description

According to the reporter: the pt had mesh surgery for hernia repair and had abdominal pain for a year. Revision surgery was done. Allegedly, the surgeon stated that the mesh ripped away from abdomen shriveled up and became sharp and made lacerations in her stomach revision and replace of mesh failed for a second time. Pt experienced severe bleeding, which required another surgery where 2nd mesh was removed and due to the damage it caused pt received a colostomy, pt states that during these procedures, she almost died twice in 2011. A surgery was done to reverse colostomy and the original hernia plus. Two additional hernias were present. Pt says she is in extreme pain constantly, it is difficult for her to stand or walk without constant pain, she has difficulty sleeping and suffers from depression.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameSURGIPRO MESH
Type of DeviceSURGIPRO MESH
Manufacturer (Section D)
COVIDIEN, FORMERLY US SURGICAL
60 middletown avenue
north haven CT 06473
Manufacturer (Section G)
COVIDIEN, FORMERLY US SURGICAL
60 middletown avenue
north haven CT 06473
Manufacturer Contact
melissa zaffin, qa
60 middletown avenue
north haven , CT 06473
2034927141
MDR Report Key2654213
Report Number1219930-2012-00535
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Other
Type of Report Initial
Report Date 05/21/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Date Manufacturer Received05/21/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/21/2012 Patient Sequence Number: 1
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