MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V-PATCH

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Event Description

Doctor reported he had used mesh for hernia repair and patient developed an infection.Large seroma became infected after several weeks post surgery, treated with antibiotics.

Manufacturer Narrative

We are unable to perform a full investigation as no sample, product code or lot number was available.Review of complaints does not show any similar reports related to a device failure.If any further info is provided a follow up report will be submitted.The other seven reports are: 1219977-2014-00036, 00037, 00038, 00039, 00040, 00041, and 00042.

• Brand Name: C-QUR V-PATCH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 5 wentworth dr.; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 5 wentworth dr.; hudson NH 03051
• Manufacturer Contact: theresa morin, complaints mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687766
• MDR Text Key: 4296586
• Report Number: 1219977-2014-00043
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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