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

Lot Number 203053224

Device Problem Nonstandard Device (1420)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994); Discharge (2225); Hernia (2240); Discomfort (2330)

Event Date 05/23/2014

Event Type  Injury  

Event Description

Caller reported in (b)(6) 2014 that she received a c-qur v-patch mesh (lot # 203053224) for her ventral hernia and experienced complications which include two surgeries for the removal of the mesh, oozing, wound opening, body pain, discomfort, abdominal pain, and recurrence of the hernia.A few days (b)(6) after the surgery the stomach incision opened with a lot of discharge and oozing and the protrusion of the hernia.She searched the fda website and read that the mesh that was inserted in her was recalled in august 2013.(recall # z19382013).She was implanted in (b)(6), 2014.She questioned her doctor about this and was told he did not know the mesh was recalled.

• Brand Name: C-QUR V-PATCH MESH
• Type of Device: MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP
• MDR Report Key: 4438945
• MDR Text Key: 5395335
• Report Number: MW5040296
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 203053224
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR