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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 PCO1510OS
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Swelling (2091); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); No Code Available (3191)
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 small bowel obstruction, bowel stuck between mesh and abdominal wall, succus underneath mesh, pinpoint size hole in the small bowel, necrotic tissue, recurrent incisional hernia, multiple adhesions, pain, defect inferior and right of mesh, infection, bowel adherence to mesh, superficial serosal tearing in bowel, periodic swelling and two chronic draining sinuses from right lower abdomen with surrounding induration. Post-operative treatment included wound vac placement, enterotomy, necrotic tissue removal from abdominal wound, recurrent incisional hernia repair with new mesh, removal of two previously placed pieces of covidien mesh due to infection, and drainage of enteric contents.

 
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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 Key8515538
MDR Text Key141972765
Report Number9615742-2019-01299
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,Followup,Followup
Report Date 10/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2014
Device MODEL NumberPCO1510OS
Device Catalogue NumberPCO1510OS
Device LOT NumberPJL00327
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 04/15/2019 Patient Sequence Number: 1
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