MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH; SURGICAL MESH

Catalog Number	0117010
Medical Device Problem Codes	Shelf Life Exceeded (1567); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is confirmed as a use related error, as the device was well within the date of expiry when provided to the facility in 2012.The ifu notes that a ¿traceability label is attached to every prosthesis package which identifies the type, size, and lot number of the prosthesis.This label should be affixed to the patient¿s permanent record to clearly identify the device which was implanted.¿ note: the traceability label also includes the lot expiry date.The ifu also instructs the user to inspect the package prior to use.Remains implanted.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient was implanted with two bard soft mesh devices.As reported during the completion of the procedure and closing the patient, the nurse realized that one of the implants was past the expiration date of 12/31/2016.It was reported that the patient had received iv ancef preoperatively and an irrigation of antibiotic solution after the procedure was completed.Additionally, the patient was kept in the hospital for an overnight stay and given 2 more doses of iv antibiotics before discharge.There was no reported patient injury and the mesh remains implanted at this time.This mdr is filed as a serious injury as precautionary measures were taken by the user facility and the patient was administered additional medication and remained in the hospital overnight.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6892043
• Report Number: 1213643-2017-00628
• Device Sequence Number: 108109
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871(17)161231(10)HUVK1708
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: 12/31/2016
• Device Catalogue Number: 0117010
• Device Lot Number: HUVK1708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/25/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 83