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

Model Number	30901
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.Device evaluated by manufacturer? not returned.
Event or Problem 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 pain and discomfort, mesh separation, recurrent hernia, mesh contraction, adhesions, seroma, risk and anxiety of surgery, and related sequelae.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.
Additional Manufacturer Narrative
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 requirements.

• Brand Name: PROLOOP MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9260332
• Report Number: 3011175548-2019-01140
• Device Sequence Number: 13835412
• Product Code: FTL
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 09/08/2021
• Device Model Number: 30901
• Device Catalogue Number: 30901
• Device Lot Number: 408278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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