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

Model Number 1000306-00

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Received report of a hair in the package.

• Brand Name: PROLITE MESH
• Type of Device: 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: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8521144
• MDR Text Key: 142210839
• Report Number: 3011175548-2019-00406
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K930669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1000306-00
• Device Catalogue Number: 1000306-00
• Device Lot Number: 438164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial