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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 8C MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PCO VENTRAL PATCH 8C MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO8VP
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

Procedure: umbilical hernia repair. According to the reporter: as per the suggested technique. The dr. Is not a regular user of this mesh (it is only the third time he has performed this procedure with this product). The hernia defect measured around 3cm, he selected this product, as the best size for this particular defect. After introducing the mesh through the defect, into the abdominal cavity, the mesh folded onto itself (away from the viscera, toward the inside of the abdomen). After numerous attempts to reposition the mesh flat against the abdominal wall/peritoneum, it eventually had to be removed. The handles did not seem to lift the other half of the mesh, but rather kept it folding double upon itself (when pulling it up). To complete the case a new piece of mesh was used. There was a slight delay in surgery (around 10 min in total), but there was no significant tissue damage or blood loss. No particulate matter came loose from the mesh/ or fell into patient abdomen.

 
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Brand NamePCO VENTRAL PATCH 8C
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
MDR Report Key6152492
MDR Text Key61734010
Report Number9615742-2016-00199
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/10/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO8VP
Device Catalogue NumberPCO8VP
Device LOT NumberPQE0277X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
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 Unkown

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