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

Catalog Number	1151935
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol xenmatrix (device #2).Additional emdrs were submitted to represent the two bard/davol mesh ¿ ventralex (device #1) and (device #3).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralex hernia patch and xenmatrix on (b)(6) 2012 and/or (b)(6) 2016 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.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 adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct brand name, product classification code and pma/510(k) #.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-2015) is considered to be a best estimate.Corrected fields: d1 (brand name), d.2b (product classification code) and g4 (pma/510(k) #) this supplemental emdr represents the xenmatrix ab (device #2).An additional supplemental emdr was submitted to represent the ventralight st w/ echo (device #1) and xenmatrix ab (device #3) 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 unspecified bard/davol ventralex hernia patch and xenmatrix on (b)(6) 2016 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2012 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device #1).Per op notes, "a ventralight st mesh using echo ps (device #1) was placed at the level of the umbilicus using tacks." on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia thereby underwent repair.Per op notes, "there were adhesions to the mesh and the hernia sac and these were taken down.A synthetic mesh was placed.On (b)6) 2016 - patient underwent repair with the implant of xenmatrix ab (device #2).(note: no op notes were provided).On (b)(6) -2020 - patient underwent repair with the implant of xenmatrix ab (device #3).(note: no op notes were provided).

• Brand Name: XENMATRIX AB
• 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 ; 4018258495
• MDR Report Key: 10343250
• Report Number: 1213643-2020-07047
• Device Sequence Number: 16344615
• Product Code: PIJ
• UDI-Device Identifier: 00801741074301
• UDI-Public: (01)00801741074301(17)170828(10)HUZH0396
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: 08/28/2017
• Device Catalogue Number: 1151935
• Device Lot Number: HUZH0396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2015
• 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 Sex: Female