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

Catalog Number	0134680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	09/17/2015
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.Note, the manufacturing date (15-feb-2010) is considered to be a best estimate.This mdr represents the composix l/p mesh (device 3).Additional supplemental emdr's were submitted to represent the composix kugel patch (device 1) and composix kugel patch (device 2).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) 2009 - patient was diagnosed with symptomatic abdominal incisional hernia thereby underwent open repair with implant of composix kugel patch (device 1).Per operative notes, ¿a midline skin incision was made over the scar tissue where the subcutaneous tissue was sharply divided.A large hernia sac was noted, which was dissected out.A composix kugel patch (device 1) was placed into the fascia and secure it with sutures.¿ on (b)(6) 2010 - patient was diagnosed with abdominal incisional hernia, adhesion thereby underwent open repair with explant of composix kugel patch (device 1) and implant of composix kugel patch (device 2).Per operative notes, ¿a midline skin incision was made in the old scar tissue.Previously placed composix kugel patch (device 1) had disrupted, which was removed.The hernia sac was dissected out.Lysis of adhesion was performed.A composix kugel patch (device 2) was placed into the fascia and secure it with sutures.¿ on (b)(6) 2011 ¿ patient was diagnosed with abdominal incisional hernia; adhesion thereby underwent open repair with explant of composix kugel patch (device 2) and implant of composix l/p mesh (device 3).Per operative notes, ¿a midline skin incision was made in the old scar tissue.The previously placed composix kugel patch (device 2) was identified.This was carefully dissected at the edge of the fascia.Two large hernia sacs were noted, which were dissected out.Lysis of adhesion was performed.A composix l/p mesh (device 3) was placed to the fascial defect and closed with sutures.¿ on (b)(6) 2015 ¿ patient was diagnosed with abdominal incisional hernia; adhesion thereby underwent open repair with explant of composix l/p mesh (device 3) and implant of xenmatrix mesh (device 4).Per operative notes, ¿a midline skin incision was made in the old scar tissue several small bowel adhesions were present, which were taken down.The hernia sac was dissected out.Previously placed composix l/p mesh (device 3) was removed.A xenmatrix mesh (device 4) was placed in the abdomen and secure it with sutures.¿.

• 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 ; 8005566756
• MDR Report Key: 23797154
• Report Number: 1213643-2025-01204
• Device Sequence Number: 5712969
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298(17)150328(10)HUUB1330
• 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: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 03/28/2015
• Device Catalogue Number: 0134680
• Device Lot Number: HUUB1330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2010
• 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: 66 YR
• Patient Sex: Male