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

Model Number 31528

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received a report of an event that while implanting mesh into the patient a half piece of plastic lining was also implanted.The packaging plastic piece was explanted (b)(6) 2015 and the mesh remains in the patient.

Manufacturer Narrative

The mesh rolls used to manufacture this mesh met specification for residual lubricant, suture retention strength and ball burst strength.Fourier-transform infrared spectrophotometry (ftir) test records showed that the mesh coating had adequate crosslinking.Sterilization records show that the lot was released.Packaging was subjected to pre and post sterile pouch seal strength testing, and met the acceptance requirements.Based on the lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture.Clinical evaluation: the handling sleeve facilitates ease handling in the sterile field.The handling sleeve that protects the c-qur mesh product is loosely, but securely place around the device with a seal on each side.The sleeve visually is clear while the mesh is a tan/yellow color.The protective sleeve has a firm, smooth plastic texture while the mesh has a woven texture that is easily discernable from the packaging.The handling sleeve provides to the user tactile, visual and auditory cues that inform the user to remove it prior to implantation.The instructions for use state that "the atrium c-qur mesh must be removed from the handling sleeve using sterile technique prior to use.".

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 5015091
• MDR Text Key: 23460970
• Report Number: 1219977-2015-00235
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Report Date: 08/11/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 31528
• Device Catalogue Number: 31528
• Device Lot Number: 218439
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR