MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS; MESH, SURGICAL, POLYMERIC

Model Number UNK PARIET PROGRIP

Device Problems Material Erosion (1214); Torn Material (3024)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the patient had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom.

Manufacturer Narrative

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

Event Description

According to the reporter: the patient had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom.An additional mesh was implanted during the hernia surgery in 2015 without his knowledge.He has had recurrent infections, nerve damage, and organ damage, pig prosthetic tissue implant, bowel damage, bladder damage, pain and an abundance of scar tissue and adhesion due to the mesh.He wanted to have the mesh removed but doctor told him it¿s not possible if removed there would be more damage to his organs.He has depression, mental health issues and taking antidepressants.

• Type of Device: MESH, 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6750920
• MDR Text Key: 81298951
• Report Number: 9615742-2017-05194
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK PARIET PROGRIP
• Device Catalogue Number: UNK PARIET PROGRIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 02/07/2018
• 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