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

Model Number	30922
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Adhesion(s) (1695); Arrhythmia (1721); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scarring (2061); Seroma (2069); Obstruction/Occlusion (2422); Blood Loss (2597); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional 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.
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 severe pain, erosion of the mesh into the small intestine, multiple infection- related procedures, removal surgery, bowel obstructions, recurrence, enterocutaneous fistula, drainage, small bowel resection, ileus, seroma, succus entericus, adhesions, mesh erosion, scar tissue, blood loss and arrythmia.Related files: (b)(4).
Additional Manufacturer Narrative
Correction section: g4.Additional information section: b5 & h6.
Event or Problem Description
Plaintiff also allegedly experienced inflammation, loss of appetite, weakness, stress and anxiety.

• Brand Name: PROLOOP MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8460792
• Report Number: 3011175548-2019-00324
• Device Sequence Number: 19586464
• Product Code: FTL
• UDI-Device Identifier: 00650862309225
• UDI-Public: 00650862309225
• 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: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 12/31/2013
• Device Model Number: 30922
• Device Catalogue Number: 30922
• Device Lot Number: 10444713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 103 KG