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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 TEM1208GR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the survey source, after using the mesh, there were patients experienced the following complications: 10 patients with chronic pain (developed chronic pain which did not resolve with standard treatment and required referral to pain specialist), 2 patients with mesh infection (unusual to have mesh infection in modern hernia practice that the wound had to be left open with antibiotics before symptoms settled), 5 patients with seroma/hematoma (expected complication which was settled on conservative treatment), 4 patients with infection (treated with antibiotics and drainage where appropriate), and 1 patient with genital complication (which required removing testicle, was a recurrent hernia).

 
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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 Key8946718
MDR Text Key156019765
Report Number9615742-2019-02912
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 08/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/30/2013
Device MODEL NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
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: 08/29/2019 Patient Sequence Number: 1
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