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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 TEM3015G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Discomfort (2330); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
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 ventral incisional hernia. It was reported that after implant, the patient experienced pain, recurrence, subcutaneous fluid, tenderness, distention, and adhesions. Post-operative patient treatment included revision surgery, separation of parts debridement of abdominal wall, removal of mesh, hardware removal, panniculectomy, smooth massive skin flaps, separation of component, application vac dressing, small eschars were excised, subcutaneous fluid suctioned away, hernia repair with new mesh, and lysis of adhesions.

 
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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 Key11717095
MDR Text Key247028943
Report Number9615742-2021-00890
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL NumberTEM3015G
Device Catalogue NumberTEM3015G
Device LOT NumberSLE00416
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/28/2011
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: 04/23/2021 Patient Sequence Number: 1
Treatment
UNKNOWN PROTACK (LOT# UNKNONW)
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