MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH; MESH, SURGICAL, POLYMERIC

Model Number	31544
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Hospital reported that they went to open the package on the sterile field for surgery the one side of the package would not open correctly.
Additional Manufacturer Narrative
The returned device was removed from the shipping box and inspected.Upon inspection the pouch appeared to have been opened from the side of the sealed pouch and the pouch was ripped into the middle of the pouch.The pouch was attempted to be opened from the top of the package and it opened properly and without issue.The mesh was still inside the pouch with the protective film still covering the mesh.There were no signs of particulate on the protective film or upon the underlying mesh.It is not known how or why the mesh pouch was torn in such a manner.The details indicated that the adhesive was defective.A review of the adhesive bond showed no defects.A review of the device history records indicates that this lot of mesh passed all quality and performance requirements.A review of the complaint history shows that there have been no other complaints for this lot of mesh in regards to the packaging opening improperly.Summary/conclusion: based on the details of the complaint, atrium medical cannot conclude that the mesh packaging was faulty.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8566864
• Report Number: 3011175548-2019-00489
• Device Sequence Number: 1731902
• Product Code: FTL
• UDI-Device Identifier: 00650862315448
• UDI-Public: 00650862315448
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2021
• Device Model Number: 31544
• Device Catalogue Number: 31544
• Device Lot Number: 438312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Device Age: YR
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1