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

Catalog Number	0108121
Medical Device Problem Code	Inadequate Service (1564)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported it was noted by the surgeon following implant, that they had implanted an expired device into the patient.The device was provided to the customer prior to the expiration date.Based on the events as reported the root cause is use error.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.As reported additional patient information could not be provided due to hippa laws.Remains implanted.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient underwent a stomal hernia repair and was implanted with a bard dulex mesh.Following the procedure the surgeon noted that the expiration date on the device was 03/30/2017.No medical or surgical intervention has been reported and the mesh remains implanted.

• Brand Name: MESH - DULEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6631454
• Report Number: 1213643-2017-00344
• Device Sequence Number: 11025078
• Product Code: FTL
• UDI-Device Identifier: 00801741011788
• UDI-Public: (01)00801741011788(17)170330(10)BRWC0005
• Combination Product (Y/N): N
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2017
• Device Catalogue Number: 0108121
• Device Lot Number: BRWC0005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1