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 Codes	Inflammation (1932); Pain (1994); Disability (2371)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided the cause of the alleged postoperative complications cannot be determined.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.The information provided is limited at this time.Should additional information be provided, this report will be updated.Remains implanted.
Event or Problem Description
It was reported that the patient was implanted with a bard/davol flat mesh for the repair of pelvic prolapse of the intestines.Since the placement of the mesh it is alleged that the patient has been disabled due to chronic pain and inflammation.In 2018 it is reported that the patient underwent a partial explant of the mesh however, as reported the complications are becoming "more and more serious and a complete removal is necessary.".
Additional Manufacturer Narrative
Based on the information provided the cause of the alleged postoperative complications cannot be determined.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.The information provided is limited at this time.Should additional information be provided, this report will be updated.This is an addendum to the initial emdr to document additional information provided (dates of implant and revision).As stated by the contact she was unable to obtain the lot number.Device remains implanted.
Event or Problem Description
It was reported that the patient was implanted with a bard/davol flat mesh for the repair of pelvic prolapse of the intestines.Since the placement of the mesh it is alleged that the patient has been disabled due to chronic pain and inflammation.In 2018 it is reported that the patient underwent a partial explant of the mesh however, as reported the complications are becoming "more and more serious and a complete removal is necessary.".

• 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: 8719428
• Report Number: 1213643-2019-05314
• Device Sequence Number: 14071603
• 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
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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; Disability