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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 PCO9X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Dehydration (1807); Purulent Discharge (1812); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Vomiting (2144); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 an incisional supr aumbilical ventral hernia. It was reported that after the underlay implant, the patient experienced infected mesh, wadded up mesh, adhesions, abdominal wall drainage, chronic wound, draining sinus tract, small bowel obstruction, edematous, inflammation, loss of domain, mass, purulent drainage, stitch granuloma, wound dehiscence, massive wound, fat necrosis, abscess, redness, serous leakage, vomiting, severely dehydrated, and recurrence. Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, open cholecystectomy, hernia repair with new mesh, small bowel resection, medication, daily wound dressing changes, bilateral subcutaneous skin flap creation, primary fascial closure, admission to hospital, suture material removed, excisional biopsy of omental mass, bilateral myofascial rectus abdominis advancement flaps, some purulent drainage/likely stitch granuloma were excised, and abdominal wall reconstruction.

 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key11861143
MDR Text Key251924673
Report Number9615742-2021-01345
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
Report Date 05/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO9X
Device Catalogue NumberPCO9X
Device LOT NumberPQG1345X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/17/2016
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: 05/20/2021 Patient Sequence Number: 1
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