MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0134113
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
At this time no conclusions can be made regarding the bard/davol composix e/x (device #2) used to treat the patient.The patient's attorney did allege surgical intervention; 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.This emdr represents the bard/davol composix e/x (device #2).An additional emdr was submitted to represent the bard/davol flat mesh (device #1).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) or an unspecified bard/davol composix e/x (device #2) on (b)(6) 2003 or (b)(6) 2011.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh (device #1) and the composix e/x (device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #2) used to treat the patient.The patient's attorney did allege 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: 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-nov-2010) is considered to be a best estimate.This supplemental emdr represents the bard/davol composix e/x (device #2).An additional supplemental emdr was submitted to represent the bard/davol flat mesh (device #1).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 bard mesh (device #1) or an unspecified bard/davol composix e/x (device #2) on (b)(6) 2003 or on (b)(6) 2011.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh (device #1) and the composix e/x (device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2003: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of bard flat mesh (device #1).Per operative notes, ¿the hernia sac was identified and dissected free.A bard flat mesh (device #1) was placed and sutured.¿ on (b)(6) 2010: patient was diagnosed with small bowel obstruction and incarcerated recurrent ventral incisional hernia with abdominal pain thereby underwent open repair with excision of mesh (device #1).Per operative notes, ¿the prior mesh was pulled away with the hernia sac.The adhesions of small bowel and prior mesh was lysed.The small bowel stuck in hernia sac was released.Enterotomy was performed.The dense adhesions were lysed.The prior mesh (device #1) was removed.The hernia sac was identified, excised and repaired using sutures.¿ on (b)(6) 2010: patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent repair with implant of composix l/p (device #2).(note: there is no operative notes provided for this procedure in mr).

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: 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: 9126470
• Report Number: 1213643-2019-09373
• Device Sequence Number: 14107005
• Product Code: FTL
• UDI-Device Identifier: 00801741031243
• UDI-Public: (01)00801741031243(17)151228(10)HUUK0376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 12/28/2015
• Device Catalogue Number: 0134113
• Device Lot Number: HUUK0376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• 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 Sex: Female