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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH SURGICAL MESH Back to Search Results
Catalog Number 0117010
Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2017
Event Type  Injury  
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 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.
 
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Brand NameBARD SOFT MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6892043
MDR Text Key87293190
Report Number1213643-2017-00628
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2016
Device Catalogue Number0117010
Device Lot NumberHUVK1708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/25/2017 Patient Sequence Number: 1
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