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

Catalog Number	0113700
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.It was alleged, the patient was treated postoperatively for a non-healing wound.The cause of the non-healing wound is unknown.Many things extrinsic to the medical device can cause poor wound healing in patients, including patient comorbidities such as obesity, and diabetes.There is no connection that can be made to identify the medical device causing or contributing to the non-healing wound.A lot number was not provided, without a lot number a review of the manufacturing records is not possible.Should additional information be obtained, a supplemental emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.
Event or Problem Description
The following was reported via (b)(4): the patient was implanted with a davol pre-shapled mesh and experienced a postoperative non-healing wound.As reported anti-infective therapy administered.

• Brand Name: BARD MESH PRE-SHAPED
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7836607
• Report Number: 1213643-2018-02986
• Device Sequence Number: 16755851
• Product Code: FTL
• UDI-Device Identifier: 00801741030697
• UDI-Public: (01)00801741030697
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 0113700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/31/2018
• 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