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

Catalog Number	1161935
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erosion (1750); Necrosis (1971); Pain (1994); Post Operative Wound Infection (2446); Insufficient Information (4580)
Date of Event	12/13/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol xenmatrix on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the xenmatrix.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-aug-2012) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, d4, g3, g6, h2, h4, h6, h10.Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol xenmatrix on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the xenmatrix.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of xenmatrix mesh.Per operative notes, ¿a midline incision was made.A unspecified previous mesh was adherent to bowel, colon and liver.The adhesions were lysed.The unspecified previous mesh was excised.A large hernia defect was identified.A xenmatric mesh was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with infected surgical wound thereby underwent open repair with excision of necrotic abdominal wall & subcutaneous tissue and application of wound vac.Per operative notes, ¿the wound was opened, and the mesh was noted to have some areas of erosion.The abdominal wall and subcutaneous tissue were necrotic.These were excised and application of wound vac.¿ (b)(6) 2012 - patient was diagnosed with infected abdominal wound thereby underwent repair with application of wound vac.Per operative notes, ¿the previous vac was removed.The wound was irrigated and application wound vac.¿ attorney alleges that patient had pain and infection.It is also alleged that patient had necrosis.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 15367876
• Report Number: 1213643-2022-96196
• Device Sequence Number: 19270049
• Product Code: FTM
• UDI-Device Identifier: 00801741031441
• UDI-Public: (01)00801741031441(17)140828(10)HUWH0513
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 08/28/2014
• Device Catalogue Number: 1161935
• Device Lot Number: HUWH0513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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; Disability
• Patient Age: 49 YR
• Patient Sex: Female