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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 PPM3030
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Scar Tissue (2060); Hernia (2240); Impaired Healing (2378); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: mesh fortiva porcine dermis 30 x 30 (rlq) (product id: pd3030, lot number: mp151801). (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 a ventral hernia. It was reported that after the inlay implant, the patient experienced mesh migration, adhesions, necrosis, fistula, omental mass, abdominal pain, open wound, anastomotic leak, loss of abdominal wall domain, infection, malnutrition, inflammation, fascia attenuation, scarring, short bowel syndrome, recurrence, and abscess. Post-operative patient treatment included removal of mesh, lysis of adhesions, debridement of necrotic skin/subcutaneous tissue/fascia/muscles, drainage of abscess, placement of wound vac, placement of drain, small bowel resection, restoration of intestinal with heineke-mikulicz, adhesiolysis, omentectomy, excision of omental mass, hernia repair with new mesh, abdominal reconstruction, right & left bilateral modified myofascial flap advancements, extensive soft tissue debridement of the fistula tract/inflamed muscle/attenuation, abdominal wall soft tissue flap advancement, and placement of malecot fistulotomy tube.

 
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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 Key11821610
MDR Text Key250876331
Report Number9615742-2021-01099
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 05/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2021
Device MODEL NumberPPM3030
Device Catalogue NumberPPM3030
Device LOT NumberSQF0283X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/22/2016
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: 05/13/2021 Patient Sequence Number: 1
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