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

Catalog Number	0123680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hematoma (1884); Seroma (2069); Hernia (2240); Insufficient Information (4580)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.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 e/x and marlex (bard flat mesh).As reported, the patient is making a claim for an adverse patient outcome against the composix e/x which was implanted on (b)(6) 2008.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
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.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-jun-2008) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b6, b7, d1, d3, d4 (catalog no, lot no, expiry date, udi), d6b, 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 unspecified bard/davol composix e/x and marlex (bard flat mesh).As reported, the patient is making a claim for an adverse patient outcome against the composix e/x which was implanted on (b)(6) 2008.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) 2008 - patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent open repair with implant of composix e/x mesh.Per operative notes, ¿a large hernia sac was identified and opened.A significant amount of bowel stuck in sac was reduced.A composix e/x mesh was placed and sutured.(b)(6) 2018 - patient was diagnosed with intra-abdominal hematoma, seroma and abdominal pain thereby underwent laparoscopic repair with evacuation of hematoma.Per operative notes, ¿the adhesions of anterior abdominal wall and omentum were taken down.A large amount of hematoma was identified and evacuated using suction device.The seroma was drained and sutured.(b)(6) 2018 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with excision of composix e/x mesh and implant of 2 seprafilm and biological mesh.Per operative notes, ¿the old mesh adherent to abdominal wall and small bowel were lysed.The entire mesh was removed.The adhesions of intra-abdominal space were taken down.Two seprafilm was placed underneath the anterior abdominal wall.A biological mesh was placed in the retro muscular space and sutured.

• Brand Name: MESH - COMPOSIX E/X
• 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: 11736977
• Report Number: 1213643-2021-03123
• Device Sequence Number: 19777657
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(17)130728(10)HUSF1201
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 07/28/2013
• Device Catalogue Number: 0123680
• Device Lot Number: HUSF1201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2008
• 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: 75 YR
• Patient Sex: Male