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

Catalog Number	1151928
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	03/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, at this time, no conclusion can be made as to the degree to which the xenmatrix ab graft may have caused or contributed to the post surgical seroma.Seroma formation is a known inherent risk with the use of any prosthesis, and is identified in the adverse reaction section of the ifu as a potential complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional information is provided, a supplemental mdr 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.Device remains implanted.
Event or Problem Description
The following was reported and is associated with clinical study (b)(4): (b)(6) 2016 - the patient was implanted with a bard xenmatrix ab.(b)(6) 2017 - the patient seen for a follow up visit.During this visit, a previously performed ct scan was reviewed and showed a superficial lower left abdominal seroma.The patient was scheduled for an open incision and drainage.The seroma is assessed as mild severity, grade iii, possibly related to the device and definitely related to the procedure.

• Brand Name: XENMATRIX AB
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6460841
• Report Number: 1213643-2017-00212
• Device Sequence Number: 18951715
• Product Code: PIJ
• UDI-Device Identifier: 00801741074271
• UDI-Public: (01)00801741074271(17)170728(10)HUZH0395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: 07/28/2017
• Device Catalogue Number: 1151928
• Device Lot Number: HUZH0395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 04/05/2017
• 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: 72 YR