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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); Adhesion(s) (1695); Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 an incisional hernia. It was reported that after implant, the patient experienced wound infection, open wound, adhesions, necrotic fascia, foul-smelling wound, mesh no incorporated, wound dehiscence, hematoma, serosal tear, fascia/external oblique on right gave way, recurrence, and free mesh. Post-operative patient treatment included revision surgery, debridement of wound, laparotomy, removal of mesh/spiral tacking metallic tackers, primary fascial closure, wound vac, left subclavian vein central line, necrotic fascia and pds sutures debrided, abdominal washout of old hematoma, debridement of fascial edges, closure of wound dehiscence, mesh reinforcement, two units of blood transfused for low preoperative hemoglobin, serosal repair with sutures, deeply fused viscera taken down, component separation attempted but abandoned, and wound irrigation.

 
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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 Key9884528
MDR Text Key188350960
Report Number9615742-2020-00668
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
Report Date 03/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2014
Device MODEL NumberPCO1510X
Device Catalogue NumberPCO1510X
Device LOT NumberPMC00556
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
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: 03/26/2020 Patient Sequence Number: 1
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