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

Model Number	UNK PARIET PROGRIP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/05/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Phone number unknown.Patient information not provided.Implant and explant date were not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Date received by mfr: since the lot number was not provided, this information cannot be determined.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 or Problem Description
According to the reporter: the patient had left inguinal hernia surgery.The patient experienced increased pain after the surgery.The patient had cryo-ablation to dead the nerves to help with the pain.The patient needed to continue to have injections as needed to help with the pain.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PARIETEX PROGRIP
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 6432373
• Report Number: 9615742-2017-05053
• Device Sequence Number: 18112106
• Product Code: FTL
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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
• Operator of Device: Health Professional
• Device Model Number: UNK PARIET PROGRIP
• Device Catalogue Number: UNK PARIET PROGRIP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other