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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO8VP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 05/10/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operatively on a hernia procedure, the surgeon thought there was only 1 hernia but there were actually 4 hernias. The surgeon then implanted the mesh and was removed it after a month. The surgical procedure took 4 hours to remove the mesh. The patient would be undergoing another reoperation to repair the mesh. It was also reported that the patient is experiencing pain at the site of the mesh removal surgery. A computed tomography shows an abnormality at the surgery site. The scan showed an accumulation of fluid was drained. Patient was then placed on an aggressive course of antibiotics. The patient had pain, redness and swelling.

 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9438611
MDR Text Key169867367
Report Number9615742-2019-03823
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO8VP
Device Catalogue NumberPCO8VP
Device LOT NumberPRD0532X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/13/2017
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: 12/09/2019 Patient Sequence Number: 1
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