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

Catalog Number	1153045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the reported abdominal pain.The patient's symptom (pain) was assessed as mild in severity and possibly related to the device and possibly related to the procedure.Medical intervention was not taken or required as such a malfunction emdr is submitted to document this event.Remains implanted.
Event or Problem Description
The following was reported and is associated with the xenmatrix ab study dvl-he-012: on (b)(6) 2018 the patient was implanted with a bard xenmatrix ab graft during hernia recto-rectus revision procedure for hernia recurrence.As reported the graft was trimmed to size and a 5cm graft overlap was maintained around the hernia defect.It is reported that on (b)(6) 2019 the patient presented with lower right sided abdominal pain which started on (b)(6) 2019.No action is being taken and no intervention is required at this time.The patient symptom of pain has been assessed by the clinician as mild in severity, "possibly related" to the study device and "possibly related" to the procedure.As reported, the pain is mild in nature and comes and goes."point tenderness at about the subcostal site of mesh fixation.".

• 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: 8789523
• Report Number: 1213643-2019-06033
• Device Sequence Number: 1999908
• Product Code: PIJ
• UDI-Device Identifier: 00801741129049
• UDI-Public: (01)00801741129049
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K162193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1153045
• Device Lot Number: HUBP2070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 54