MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH ¿ DULEX; SURGICAL MESH

Catalog Number	0120301
Medical Device Problem Codes	Material Disintegration (1177); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Contact alleges, about 17 years post-implant of the dulex mesh the patient experienced discomfort, mesh disintegration, obstruction and abdominal pain.Based on the information available at this time, no conclusions can be made.Adhesion formation is a known inherent risk of surgery and is listed as a possible complication in the adverse reactions section of the instructions for use (ifu) supplied with the device.
Event or Problem Description
As reported, during an incisional hernia repair procedure on (b)(6) 2004, the patient was implanted with a bard/davol dulex mesh.It was reported, about 6 years later in 2010 the patient underwent additional surgery to remove abdominal wall scarring.As reported on (b)(6) 2021, the patient experienced excruciating pain and presented to the hospital emergency room.As reported, a ct scan was performed and identified 2 bowel blockages and a twisted area of bowel.It was reported the surgeon would not perform any surgical procedure and administered a ¿dye¿ to temporarily resolve the blockages and twisted bowel.As reported, the patient has continued with significant abdominal bloating/swelling, and the patient¿s abdomen is hard to the touch and painful.As reported the patient has tried multiple remedies such as gas-x, mint tea, multiple doctor visits with no relief.Contact reports the patient experienced health issues related to the ¿mesh disintegrating and allows intestines to grow into the mesh.¿ per the contact, the mesh has ¿welded itself against the bowels and skin causing trouble eating and bloating.¿ it is reported that the patient is waiting for surgery in the near future.

• Brand Name: MESH ¿ DULEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; bozeman 59715
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14141672
• Report Number: 1213643-2022-00162
• Device Sequence Number: 15016144
• Product Code: FTL
• UDI-Device Identifier: 00801741011894
• UDI-Public: (01)00801741011894
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0120301
• Device Lot Number: 41AOBR13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female