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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO12X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Internal Organ Perforation (1987); Perforation (2001); Pleural Effusion (2010); Sepsis (2067); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: pco20, lot number: plb00291; pco12x , lot number: plh00283. 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 incarcerated incisional hernias. It was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions, recurrent incarcerated incisional hernias requiring placement of new mesh for repair, dense adhesions (lysed over 2. 5 hours), enterotomy repair, effaced bowel, excision, infection, abdominal abscess, small bowel perforation, foul-smelling puss from abdominal wound, placement of wound vac because they were unable to close the abdominal wall d/t bowel perforation and open wound, primary repair of small bowel perforation and exchange of wound vac, abdominal wound sepsis, wound exploration, removal of wound vac, incision and drainage of right lateral abdominal wall, placement of new mesh to repair defect, small bowel obstruction. After treatment, the patient experienced revision surgery.

 
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Brand NameMESH SOFRADIM - PARIETEX¿ OPTIMIZED 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 Key8600610
MDR Text Key144728427
Report Number9615742-2019-01674
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,Followup,Followup,Followup
Report Date 01/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2013
Device MODEL NumberPCO12X
Device Catalogue NumberPCO12X
Device LOT NumberPLI00523
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2019
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: 05/10/2019 Patient Sequence Number: 1
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