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

Catalog Number	0134680
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Insufficient Information (4580)
Date of Event	07/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix l/p on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against the composix l/p.It is alleged that the patient had revision surgery on (b)(6) 2022.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 that the patient had subsequent surgical intervention and "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.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.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "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: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event 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-may-2009) is considered to be a best estimate.Updated fields: a2, b4, b5, b6, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), d6b (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected field: b3 (date of event).This supplemental emdr represents the bard/davol¿ composix l/p mesh (device 2).An additional supplemental emdr was submitted to represent the bard/davol - composix l/p 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.H3 other text: not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix l/p on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against the composix l/p.It is alleged that the patient had revision surgery on (b)(6) 2022.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) 2009 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of two composix l/p mesh (device 1 and 2).Per op notes, "an incision was made to the left lower abdomen, two composix l/p mesh (device 1 and 2) were placed using prolene sutures." (b)(6) 2022 - patient was diagnosed with large bowel obstruction thereby underwent repair with partial removal of mesh and extensive lysis of adhesions.Per op notes, "there were dense adhesions in the prior mesh, all of these were lysed.Also had a recurrent incisional hernia in the left upper quadrant.Some of the hernia mesh had to be removed." (b)(6) 2022 - patient was diagnosed with large bowel obstruction and wound infection thereby underwent repair with removal of mesh (device 1 and 2), lysis of adhesions.Per op notes, "adhesions were taken down, identified the wound infection.The mesh (device 1 and 2) were completely removed.".

• Brand Name: MESH - COMPOSIX L/P
• 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: 17783855
• Report Number: 1213643-2023-093719
• Device Sequence Number: 5492624
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298(17)140628(10)HUTE1293
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 06/28/2014
• Device Catalogue Number: 0134680
• Device Lot Number: HUTE1293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2009
• 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: 71 YR
• Patient Sex: Female