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

Catalog Number	0144680
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
At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.No medical records have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix l/p (device #2).An additional emdr was submitted to represent the bard/davol ventralight st (device#1).An additional emdr was submitted to represent the bard//davol ventralight st (device #3).An additional emdr was submitted to represent the bard/davol ventrio st (device #4).Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2011: the patient underwent surgery for implant of a bard/davol ventralight st(device #1).On (b)(6) 2013: the patient underwent surgery for implant of a bard/davol composix l/p(device #2).On (b)(6) 2015: the patient underwent surgery for implant of a bard/davol ventralight st(device #3).On (b)(6) 2016: the patient underwent surgery for implant of a bard/davol ventrio st(device #4).The patient is making a claim for an adverse patient outcome against the ventralight st(device #1), composix l/p (device #2), ventralight st (device #3), and ventrio st (device #4).The 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.

• Brand Name: 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: 7981487
• Report Number: 1213643-2018-03611
• Device Sequence Number: 1381024
• Product Code: FTL
• UDI-Device Identifier: 00801741031359
• UDI-Public: (01)00801741031359
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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: 11/28/2014
• Device Catalogue Number: 0144680
• Device Lot Number: HUWJ1835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/18/2018
• 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