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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 TEM1509G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Hematoma (1884); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Seroma (2069); Urinary Tract Infection (2120); Hernia (2240); Injury (2348); Post Operative Wound Infection (2446); Blood Loss (2597); No Code Available (3191)
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 survey source, following using the mesh, there were 2 patients had recurrence, 5 patients experienced chronic pain (pain over several weeks), 2 patients had inflammation, 2 patients had seroma/hematoma, 2 patients had infection (wound infection, abdominal wall cellulitis, urinary tract infection), 2 patients experienced per-operative complications (visceral injury, hemorrhage, severe bleeding), and 1 patient had re-operation for post-operative incisional hernia at the trocar site.

 
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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 Key8947681
MDR Text Key156090445
Report Number9615742-2019-02927
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
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 MODEL NumberTEM1509G
Device Catalogue NumberTEM1509G
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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