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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 PCO1510X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Dyspnea (1816); Edema (1820); Fever (1858); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pleural Effusion (2010); Pulmonary Edema (2020); Renal Failure (2041); Scar Tissue (2060); Scarring (2061); Sepsis (2067); Seroma (2069); Swelling (2091); Chills (2191); Discharge (2225); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Blood Loss (2597); Bowel Perforation (2668); Fibrosis (3167); No Code Available (3191)
Event Type  Death  
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 abscess, adhesions, draining open wound, phlegmon, infection, mesh was loose and hanging freely, and small bowel / enterocutaneous fistula. Post-operative patient treatment included abscess/incision drainage, debridement of abscess, wound vac, excision of phlegmon, mesh removal, lysis of adhesions, repair of small bowel enterotomies, small bowel resection, primary anastomosis, replacement of gastrostomy feeding tube, hernia repair with new mesh, jejunostomy tube placement, wound closure with demaclose device, irrigation, and debridement of abdominal wall.

 
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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 Key10379896
MDR Text Key202054174
Report Number9615742-2020-01754
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/17/2020
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 EXPIRATION Date09/30/2018
Device MODEL NumberPCO1510X
Device Catalogue NumberPCO1510X
Device LOT NumberPNJ0054X
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 Manufactured10/16/2013
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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