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

Catalog Number	1161520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.As reported, one month post implant of the xenmatrix graft, the patient presented with a pus pocket behind the graft and underwent explant.There were no signs of infection and as reported, the surgeon suspects the patient had a reaction to the graft.Allergic reaction is identified as a potential complication in the adverse reaction section of the instructions-for-use, supplied with the device.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot (b)(4) released for distribution in april, 2021.Note, the date of explant is estimated as on (b)(6) 2022, based on the information available.
Event or Problem Description
As reported, during a colostomy reversal procedure on (b)(6) 2021, a bard/davol xenmatrix graft (porcine) was implanted in the patient.It was reported that one month post implant, on (b)(6) 2022, the patient presented with a pus pocket behind the graft.As reported, the pocket was cultured, it was sterile pus and the graft was explanted.As reported, the surgeon indicated that the patient did not have any infection since the culture was negative.As reported, the surgeon felt that the patient had some type of reaction to the xenmatrix graft (porcine).

• 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
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14025846
• Report Number: 1213643-2022-00137
• Device Sequence Number: 14957445
• Product Code: FTM
• UDI-Device Identifier: 00801741031410
• UDI-Public: (01)00801741031410
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: 02/28/2023
• Device Catalogue Number: 1161520
• Device Lot Number: HUFQ0280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male