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); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	06/17/2020
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, including disability, hernia recurrence, pain and revision surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.Review of manufacturing records indicate product was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.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.H3 other text : sample not returned.
Event or Problem Description
Attorney alleges that the patient underwent hernia repair surgery and was implanted with composix l/p mesh on or around (b)(6) 2017.On or around (b)(6) 2020, the patient underwent revision surgery due to the defective qualities of the mesh.It is alleged that between (b)(6) 2017 and the present, patient suffered from recurrent hernia requiring multiple visits, subsequent hospitalization and surgery to repair the recurrent hernia.It is also alleged that the patient suffered and will continue to suffer severe and permanent personal injuries including but not limited to pain, suffering and disability.

• 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: 17570966
• Report Number: 1213643-2023-00295
• Device Sequence Number: 12980938
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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: 01/28/2021
• Device Catalogue Number: 0134680
• Device Lot Number: HUAP0105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2016
• 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; Disability; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female