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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); Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Impaired Healing (2378)
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 hernia. It was reported that after implant, the patient experienced severe pain, infection, (b)(6), recurrence, non-healing wound, purulent material, abdominal pain, dehiscence, dehisced mesh, granulation tissue, and adhesions. Post-operative treatment included revision surgery, debridement, admission to hospital, hernia repair with new mesh, excision debridement of skin/subcutaneous tissue/fascia/muscle, subcutaneous flaps to allow primary closure, complex skin closure with elevated skin flaps bilaterally, use of spy leak system, antibiotics, skin/granulation tissue excised, and mesh removal.

 
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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 Key10244914
MDR Text Key197940706
Report Number9615742-2020-01452
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 07/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2015
Device MODEL NumberPCO9X
Device Catalogue NumberPCO9X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
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: 07/08/2020 Patient Sequence Number: 1
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