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

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and the bard/davol device used to treat the patient.The patient's attorney did not allege any specific device failure and no medical records have not been provided.Based on the limited information provided at this time, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device.Should additional information be provided, a supplemental emdr will be submitted.This emdr represents the bard/davol composix lp (device 2); additional emdrs will be submitted to represent the bard/davol composix kugel (device 1) and the bard/davol composix kugel (device 3).The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2007 - the patient underwent surgery for implant of a bard/davol composix kugel (device 1).On (b)(6) 2010 - the patient underwent surgery for implant of a bard/davol composix lp (device 2).On (b)(6) 2015 - the patient underwent surgery for implant of an unspecified bard/davol composix kugel (device 3).The patient is making a claim for an adverse patient outcome against two composix kugel mesh (device 1 and 3) and the composix lp (device 2).As reported, the patient's attorney alleges a general claim related to the composix kugel (devices 1 and 3) and the composix lp (device 2) "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained.".

• Brand Name: MESH - COMPOSIX L/P
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7557107
• Report Number: 1213643-2018-01748
• Device Sequence Number: 16648704
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 03/28/2014
• Device Catalogue Number: 0134810
• Device Lot Number: HUTC0742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability