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

Model Number	1001212-00
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Cellulitis (1768); Fistula (1862); Unspecified Infection (1930); Seroma (2069); Impaired Healing (2378); Obstruction/Occlusion (2422); Blood Loss (2597); Fluid Discharge (2686); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirement.
Event or Problem Description
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced infected mesh, drainage, abscess, fistula, multiple infection-related procedures, recurrence, bowel obstruction, component separation, dehiscence, sinus tract, seroma, non-healing wound, unincorporated mesh, enterococcus, debridement, cellulitis and blood loss.This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.

• Brand Name: PROLITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8462726
• Report Number: 3011175548-2019-00333
• Device Sequence Number: 1436163
• Product Code: FTL
• UDI-Device Identifier: 00650862300109
• UDI-Public: 00650862300109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K930669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 08/31/2015
• Device Model Number: 1001212-00
• Device Catalogue Number: 1001212-00
• Device Lot Number: 10690976
• Was Device Available for Evaluation?: No
• Device Age: YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/28/2019
• 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
• Patient Age: 68 YR
• Patient Weight: 105