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

Catalog Number	1151935
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.Information regarding the pre-implant condition of the patient and the implant procedure are limited at this time.Our records show the lot was manufactured and sterilized per procedure with no anomalies noted.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided, 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.
Event or Problem Description
It is reported that on (b)(6) 2018 the patient underwent a "wound closure with mesh bridge" using a xenmatrix ab graft.As reported, the following day the patient's wound dehisced and allegedly the xenmatrix ab graft was completely dissolved.As reported, the xenmatrix ab graft was not implanted into an infected wound.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7272637
• Report Number: 1213643-2018-00290
• Device Sequence Number: 13710134
• Product Code: PIJ
• UDI-Device Identifier: 00801741074301
• UDI-Public: (01)00801741074301
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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 Expiration Date: 01/28/2018
• Device Catalogue Number: 1151935
• Device Lot Number: HUAN0730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/15/2018
• 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
• Patient Age: 21 YR