MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH PROLITE ULTRA SHEETS; MESH, SURGICAL, POLYMERIC

Model Number	30715
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.Not returned.
Event or Problem Description
Received a report that stated patient had abdominal pain on most days with some resulting in gp visits.On two of these occasions doctor sent patient to emergency room.Patient outcome/consequences: at the visit to emergency department it was suggested that the pain may be associated with the mesh implant and that i should seek specialist advice.My gp referred me to the surgeon who inserted the mesh.He examined me and reported that the problem was not with the mesh but lateral to it and that it was likely that i had a chronic muscular strain which is being reinjured by my activities and that there was nothing he could do for me.Not withstanding this, i have significant pain on most days even when doing nothing!.
Additional Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium medical corporation can find no fault with the product.This lot of mesh passed all quality and performance requirements.

• Brand Name: MESH PROLITE ULTRA SHEETS
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10163040
• Report Number: 3011175548-2020-00810
• Device Sequence Number: 3536137
• Product Code: FTL
• UDI-Device Identifier: 00650862307153
• UDI-Public: 00650862307153
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K002093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 30715
• Device Catalogue Number: 30715
• Device Lot Number: 206449
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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: Required Intervention