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

Catalog Number	0134790
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	01/13/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix lp on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against the composix lp.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 "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: 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-2009) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), d6b (date of explant), g3, g6, h2, h4, h6, h10.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 an unspecified bard/davol composix lp on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against the composix lp.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 recurrent incisional hernia, adhesion thereby underwent laparoscopic repair with the implant of the bard composix l/p mesh.Per operative notes, ¿hernia sac was dissected.Bard composix l/p mesh was placed in intraabdominal area and sutured.¿ (b)(6) 2010 - patient was diagnosed with abdominal wall infected hematoma, abscess, adhesions thereby underwent open repair with partially explant of bard composix l/p mesh.Per operative notes, ¿hernia sac was dissected.Abdominal drainage of abscess was made.Vac was placed to wound area.Bard composix l/p mesh was removed.¿ (b)(6) 2010 - patient was diagnosed with enterocutaneous fistula, wound thereby underwent open repair with wound exploration, primary closure of enterocutaneous fistula with placement of fibrin sealant and wound vac.Per operative notes, ¿wound exploration was performed.Previously placed unknown old mesh was removed.Once complete irrigation was carried out then fibrin sealant was placed.Then wound vac with good hemostasis was applied.¿ (b)(6) 2011 - patient was diagnosed with small bowel, mesh infection, hernia recurrence, adhesion thereby underwent open repair with fully explanted of bard composix l/p mesh and implant one synthetic mesh.Per operative notes, ¿all adhesions were taken down.Hernia sac was excised.Bard composix l/p mesh was fully excised from abdominal wall.One synthetic mesh was placed and sutured.¿.

• 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: 10300853
• Report Number: 1213643-2020-06821
• Device Sequence Number: 16857329
• Product Code: FTL
• UDI-Device Identifier: 00801741031304
• UDI-Public: (01)00801741031304(17)131228(10)HUTA0996
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 12/28/2013
• Device Catalogue Number: 0134790
• Device Lot Number: HUTA0996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2009
• 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: Disability; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female