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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015OS
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422)
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 hernia. It was reported that after implant, the patient experienced pain, recurrence, wrinkled mesh, small bowel obstruction, open wound, infection, abscess, adhesions, and folded mesh. Post-operative patient treatment included revision surgery, removal of mesh, hernia repair with new mesh, nasogastric tube decompression, bilateral external oblique component separation, abdominal wall reconstruction, permanent suture removed, and wound vac placement.

 
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Brand NameMESH SOFRADIM - PARIETEX COMPOSITE MESH
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 Key10804493
MDR Text Key215146750
Report Number9615742-2020-02469
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 11/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/30/2012
Device MODEL NumberPCO2015OS
Device Catalogue NumberPCO2015OS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2020
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: 11/06/2020 Patient Sequence Number: 1
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