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

Model Number UNK PARIET PROGRIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/05/2014

Event Type  Injury  

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 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.

Manufacturer Narrative

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

• Brand Name: UNKNOWN PARIETEX PROGRIP
• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6432373
• Report Number: 9615742-2017-05053
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNK PARIET PROGRIP
• Device Catalogue Number: UNK PARIET PROGRIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Outcome(s): Other