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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TMP2015G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Anemia (1706); Death (1802); Fever (1858); Inflammation (1932); Respiratory Distress (2045); Scar Tissue (2060); Septic Shock (2068); Shock (2072); Tissue Damage (2104); Ulcer (2274); Injury (2348); Impaired Healing (2378); No Code Available (3191)
Event Date 03/03/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, it was reported that initial case was completed and mesh was implanted. However, the wound did not heal properly. Evisceration was noted and was resolved by re-operation. However, upon removing the mesh to treat evisceration, the mesh was stuck to the small intestine and led to the resection of the anastomosis. Patient was hospitalized and has not been discharged. Patient was prescribed with antibiotics and analgesics.

 
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Brand NamePROGRIP
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 Key9875467
MDR Text Key186091598
Report Number9615742-2020-00625
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 06/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTMP2015G
Device Catalogue NumberTMP2015G
Device LOT NumberSSB0107X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/14/2018
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: 03/24/2020 Patient Sequence Number: 1
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