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

Catalog Number	1161928
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378); Insufficient Information (4580)
Date of Event	01/21/2015
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 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) 2010 and/or (b)(6) 2012 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all the devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges 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: h.11: this is an addendum to the initial emdr submitted (1213643-2021-08839).This supplemental emdr has been submitted to report the corrected gender and event details due to incomplete implant date being visible on legal claim form.This emdr represents the bard/davol xenmatrix (device #2).Additional emdrs were submitted to represent the two bard/davol ventralex (device #1 and device #3).Should additional information be provided, a supplemental emdr will be submitted.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.H3 other text : 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) 2010 and/or (b)(6) 2012 and/or (b)(6) 20xx (incomplete date visible on legal claim).As reported, the patient is making a claim for an adverse patient outcome against all the devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.
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) 2010 and/or (b)(6) 2012 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all the devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2010 ¿ patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of xenmatrix (device #1).Per op notes, ¿the hernia defect was dissected out.A xenmatrix (device #1) was placed right over the omentum and sutured to the edges of posterior abdominal wall and anterior fascia circumferentially.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #2).Per op notes, ¿a small hernia defect was found.The previous mesh (device#1) was found to be intact lateral to the hernia defect.A ventralex mesh (device #2) was placed into abdomen and sutured.¿ (b)(6) 2015 ¿ patient was diagnosed with recurrent incisional hernia and infected mesh and nonhealing wound thereby underwent open repair with the removal of mesh (device #1, #2).Per op notes, ¿the mesh (device #1, #2) was dissected circumferentially and excised.Adhesiolysis was performed.A xenmatrix (device #3) was placed in an intraperitoneal fashion with omentum interposed between mesh and underlying viscera and sutured.¿.
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 the sex of the patient.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-mar-2010) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), d6.A (date of implant), d6.B (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected field: a3 (sex).This supplemental emdr represents the bard/davol xenmatrix (device #1).Additional supplemental emdrs were submitted to represent the bard/davol mesh - ventralex (device #2) and bard/davol xenmatrix (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.H3 other text : not returned.

• 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 ; 4018258495
• MDR Report Key: 12860115
• Report Number: 1213643-2021-08839
• Device Sequence Number: 17295518
• Product Code: FTM
• UDI-Device Identifier: 00801741031434
• UDI-Public: (01)00801741031434(17)120328(10)HUUCBL02
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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: 03/28/2012
• Device Catalogue Number: 1161928
• Device Lot Number: HUUCBL02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 06/26/2025
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 11/29/2021; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2010
• 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: 64 YR
• Patient Sex: Male