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

Catalog Number	0144680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This mdr represents the composix l/p using echo mesh (device 1).An additional supplemental emdr was submitted to represent the composix l/p mesh (device 2).Note, the manufacturing date (15-jul-2018) is considered to be a best estimate.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
Per information provided: on (b)(6) 2020 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with implant of composix l/p using echo mesh (device 1).Per op notes, ¿omental adhesions were taken down.The hernia defect was noted and reduced.A composix l/p using echo mesh (device 1) was placed and tacked circumferentially using spiral tacks.¿ on (b)(6) 2020 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device 2).Per op notes, ¿omental adhesions were taken down.The prior mesh (device 1) was noted to be just below the fascial defect.The hernia defect was reduced.A composix l/p mesh (device 2) was placed and tacked circumferentially.¿ on (b)(6) 2021 - patient was diagnosed with recurrent incisional hernia and diverticulosis thereby underwent laparoscopic converted to open repair with excision of composix l/p using echo mesh (device 1) and composix l/p (device 2).Per op notes, ¿dense adhesions between omentum and prior meshes (device 1 and 2) were lysed.There was a recurrent hernia and reduced.All the prior abdominal meshes (device 1 and 2) were excised end removed.Sigmoidectomy was performed.The defect was repaired primarily with sutures.¿.

• Brand Name: MESH - COMPOSIX L/P W/ ECHO
• 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 ; 8005566756
• MDR Report Key: 24939503
• Report Number: 1213643-2026-00533
• Device Sequence Number: 14744614
• Product Code: FTL
• UDI-Device Identifier: 00801741031359
• UDI-Public: (01)00801741031359(17)200728(10)HUCU2163
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 07/28/2020
• Device Catalogue Number: 0144680
• Device Lot Number: HUCU2163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2018
• 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: 58 YR
• Patient Sex: Female