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

Catalog Number	1161015
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Constipation (3274)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient with a history of prior abdominal surgeries underwent implant of the bard/davol xenmatrix graft and is experiencing pain, tightness and bowel issues for which he is being treated with pain medication.The patient has undergone two mri, with no findings.At this time it is unknown what is causing the patient¿s reported postoperative symptoms.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as a best estimate based on the reported symptoms four months of post implant.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.
Event or Problem Description
As reported, the patient had a number of abdominal surgeries and needed the abdominal rectus muscles reattached and repaired on the left side.As reported, the patient underwent a bilateral reinforcement with implant of an unspecified bard/davol xenmatrix graft on (b)(6) 2020, which was used as an overlay and sutured at the left pubic bone along the inguinal and external oblique and rectus muscles.It was reported that about 4 months post op, the patient started to experience significant pain and tightness, as described ¿feels like a squeezing of his bowels, significant stretching from his rib cage to his pubic bone.¿ as reported, the patient had difficulty with bowels and took multiple laxatives; the patient reached out to the surgeon who performed the surgery who ordered an mri on two separate occasions with no findings.As reported, the patient had a prescription for narcotics but chose to take otc pain medication as the narcotic pain medication causes constipation and did not want to cause any more issues with his bowels.It was also reported that the patient continues to feel a significant stretching in abdomen with associated pain.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11607331
• Report Number: 1213643-2021-20064
• Device Sequence Number: 16899330
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: 1161015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/02/2021
• 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: 75 YR