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

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Purulent Discharge (1812); Necrosis (1971); Pain (1994); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges 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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery with implant of an unspecified bard/davol composix l/p on (b)(6) 2010.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the composix l/p.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Event or Problem Description
Attorney alleges that the patient underwent surgery with implant of an unspecified bard/davol composix l/p on (b)(6) 2010.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the composix l/p.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device #1).Per operative notes, ¿the hernia defect was identified and reduced.The adhesions were lysed.A composix l/p mesh (device #1) was placed and tacked.¿ (b)(6) 2016 - patient was diagnosed with recurrent incisional ventral hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per operative notes, ¿the adhesions were lysed.The hernia defect was identified and repaired with synthetic mesh.¿ (b)(6) 2017 - patient was diagnosed with bowel obstruction and incarcerated recurrent incisional hernia thereby underwent open repair with implant of xenmatrix mesh (device #2).Per operative notes, ¿the hernia sac was identified and opened.All the adhesions of omentum, bowel and hernia sac were taken down.The old mesh was well intact.A xenmatrix mesh (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with seroma and murky fluid extruding thereby underwent open repair with excision of composix l/p mesh (device #1).Per operative notes, ¿the tissue pocket with murky fluid with yellow fibrinous material was identified and suctioned.The old mesh was removed completely.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges 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-feb-2008) 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.

• 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: 8525065
• Report Number: 1213643-2019-03167
• Device Sequence Number: 2689580
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311(10)HUSB1134
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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 Catalogue Number: 0134810
• Device Lot Number: HUSB1134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2008
• 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: 62 YR
• Patient Sex: Female