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

Catalog Number	1162025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	11/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix, the patient was diagnosed with wound dehiscence.The clinician has assessed the patient¿s postoperative course as possibility related to the study device and possibly related to the procedure.However, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 35 units released for distribution in february, 2015.
Event or Problem Description
Alleged per clinical trial dvl-he-020: on (b)(6) 2015, the subject patient underwent first time recurrent incisional suprapubic open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in sublay fashion, fixated using vicryl sutures with interrupted stitch technique.The fascia closure and full skin closure was achieved using sutures.The patient was discharged from the hospital on (b)(6) 2015.Concomitant procedures include panniculectomy, lysis of adhesion(s).On (b)(6) 2015, the subject patient was diagnosed with wound dehiscence.The patient underwent ct scan which shows no hernia recurrence/fluid collections and the ae was resolved on (b)(6)2016.The ae is clinically assessed to be of mild severity, possibly related to the study device and possibly related to the procedure and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event).

• 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: 15294320
• Report Number: 1213643-2022-00593
• Device Sequence Number: 2805942
• Product Code: FTM
• UDI-Device Identifier: 00801741031465
• UDI-Public: (01)00801741031465
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: 01/28/2017
• Device Catalogue Number: 1162025
• Device Lot Number: HUYL0198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2015
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 125 KG