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); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Injury (2348)
Date of Event	09/11/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent 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 for implant of unspecified bard/davol composix l/p, perfix plug and xenmatrix ab on (b)(6) 2010 and/or (b)(6) 2014 and/or (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against the composix l/p.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent 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-jan-2011) is considered to be a best estimate.This supplemental emdr represents the mesh - composix l/p (device #2).An additional emdr were submitted to represent the perfix plug (device #1) and xenmatrix ab (device #3).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 unspecified bard/davol composix l/p, perfix plug and xenmatrix ab on (b)(6) 2010 and/or (b)(6) 2014 and/or (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against the composix l/p.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2010 ¿ patient was diagnosed with reducible left inguinal hernia and incarcerated umbilical hernia thereby underwent open repair with the implant of perfix plug (device #1) for left inguinal hernia.Per op notes, ¿a small perfix plug (device #1)placed into the properitoneal space through the internal ring and onlay patch was placed over the internal ring secured using sutures.An umbilical hernia was repaired using sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of composix l/p mesh (device #2).Per op notes, ¿dense adhesions to the previous hernia mesh were taken down completely.The previously placed mesh was well intact.A composix l/p mesh (device #2) was placed over the defect and tacked.¿ (b)(6) 2015 ¿ patient had abdominal pain and was diagnosed with recurrent incarcerated abdominal wall hernia thereby underwent open repair with the removal of meshes (device #1, #2) and implant of xenmatrix ab (device #3).Per op notes, ¿previously placed meshes (device #1, #2) were dissected free from the surrounding fascia were excised.Adhesions were lysed.A xenmatrix ab biological mesh (device #3) was placed in the peritoneal cavity and sutured.¿ (b)(6) 2015 ¿ patient had pain and was diagnosed with hematoma; abdominal wall seroma thereby underwent incision & drainage of hematoma.Per op notes, ¿there was a large seroma present was drained.¿ (b)(6) 2015 ¿ patient was diagnosed with abdominal wall abscess thereby underwent open repair with excision and drainage of abdominal wall abscess.Per op notes, ¿abscess cavity between the fascia and the biological mesh (device #3) was drained.¿ (b)(6) 2016 ¿ patient was diagnosed with abscess of abdominal wall thereby underwent incision and drainage of abscess.Per op notes, ¿purulent material was noted.¿.

• 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: 9557375
• Report Number: 1213643-2020-00103
• Device Sequence Number: 2426692
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298(17)160128(10)HUVA0626
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 01/28/2016
• Device Catalogue Number: 0134680
• Device Lot Number: HUVA0626
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2011
• 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: 36 YR
• Patient Sex: Female