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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPM1515X3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930); Necrosis (1971); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Ascites (2596)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, bowel obstruction, wound infection, infected mesh, abscess,fluid collection, serosanguinous fluid, and necrotic tissue. Post-operative patient treatment included revision surgery, removal of mesh, removal of necrotic tissue, repair of hernia, debridement of infected wound, drainage catheter placement, and drainage of abdominal wall abscess.

 
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Brand NamePARIETENE
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 Key10382079
MDR Text Key202111759
Report Number9615742-2020-01756
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPPM1515X3
Device Catalogue NumberPPM1515X3
Device LOT NumberSRG1327X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/24/2017
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: 08/07/2020 Patient Sequence Number: 1
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