MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP

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.

• Brand Name: PROGRIP
• 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 Key: 8954785
• MDR Text Key: 156271885
• Report Number: 9615742-2019-02977
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• 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 Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TMP3015G
• Device Catalogue Number: TMP3015G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other