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

Model Number 1000606-00

Device Problem Off-Label Use (1494)

Patient Problems Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced chronic pain, inflammation, swelling, vaginal scarring, vaginal bleeding, constipation, organ perforation, severe nerve damage and revision surgery on (b)(6) 2020 with additional surgeries.Note: atrium¿s mesh was used off-label for pelvic organ prolapse and/or stress urinary inconvenience repair surgery.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.

Manufacturer Narrative

Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirement.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

• Brand Name: MESH PROLITE SHEETS
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 14459757
• MDR Text Key: 292219664
• Report Number: 3011175548-2022-00144
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862300079
• UDI-Public: 00650862300079
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 1000606-00
• Device Catalogue Number: 1000606-00
• Device Lot Number: 10819798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female