MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH; SURGICAL MESH

Catalog Number	0112670
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the information provided post implant the patient presented with chronic pelvic / vaginal pain and bowel dysfunction and underwent explant of the mesh.No additional information has been provided to date.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.The cause of the patient postoperative complications cannot be determined at this time.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was reported to the (b)(6): per the information provided post implant (bard flat mesh) the patient experienced, severe chronic pelvic and vaginal pain, bowel dysfunction.The information states that the patient underwent removal of the sacrocolpopexy mesh after the mdt.

• Brand Name: BARD FLAT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9675852
• Report Number: 1213643-2020-01046
• Device Sequence Number: 2383196
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 0112670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention