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

Model Number	30801
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069)
Type of Reportable Event	Serious Injury
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 requirement.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 curled mesh, pain, lysis of adhesions, incarcerated recurrent hernia with new mesh, additional surgery, 5ml blood loss, seroma, scar tissue, drainage and abdominal binder placed.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.

• Brand Name: PROLITE ULTRA
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 12595508
• Report Number: 3011175548-2021-01043
• Device Sequence Number: 4201042
• Product Code: FTL
• UDI-Device Identifier: 00650862308013
• UDI-Public: 00650862308013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 10/31/2018
• Device Model Number: 30801
• Device Catalogue Number: 30801
• Device Lot Number: 10916479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention