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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP

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SOFRADIM PRODUCTION SAS PROGRIP Back to Search Results
Model Number TMP3015G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Urinary Tract Infection (2120); 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, post-operatively, there was 1 patient experienced recurrence, 1 patient had seroma/hematoma, and 1 patient experienced infection (wound infection, abdominal wall cellulitis, urinary tract infection) but the mesh was taken out.

 
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Brand NamePROGRIP
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 Key8954785
MDR Text Key156271885
Report Number9615742-2019-02977
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 09/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTMP3015G
Device Catalogue NumberTMP3015G
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
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: 09/03/2019 Patient Sequence Number: 1
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