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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2520FX
Device Problem Hole In Material (1293)
Patient Problems Pain (1994); Vomiting (2144); Injury (2348)
Event Date 04/17/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the patient underwent a laparoscopic incisional hernia repair using parietex mesh. A secure strap (ethicon device) and sutures embedded in mesh parietex composite mesh were used for fixation. Post-op, the patient went home, and approximately 24 hours after surgery, reported vomiting, a feeling of fullness, and pain. The surgeon suspected bowel obstruction, so the patient was readmitted to hospital, and underwent an additional operation. When patient was readmitted for post op surgery, the bowel had protruded through the center of the mesh. Due to the bowel sticking to the mesh, injury was caused to the small bowel. It did not fistulate. The hole in the mesh was closed with prolene suture. The mesh was not removed.
 
Manufacturer Narrative
(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information provided - lot number and expiration date.
 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-016 00
FR F-01600
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-016 00
FR F-01600
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6543847
MDR Text Key109658632
Report Number9615742-2017-05122
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberPCO2520FX
Device Catalogue NumberPCO2520FX
Device Lot NumberPQC0565X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/04/2017 Patient Sequence Number: 1
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