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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115311
Device Problems Material Frayed (1262); Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 08/08/2016
Event Type  Malfunction  
Manufacturer Narrative

The returned sample has been evaluated. This was reported as an out of box condition and the returned sample did not appear to be contaminated. The evaluation finds for tears/ frays along the edge seal of the device. Also noted are two areas of torn mesh both close to the edge of the device. A review of the manufacturing records found the lot was manufactured to specification with no anomalies. Based on the event as reported, review of the manufacturing records and the sample evaluation, root cause is undetermined at this time. However, unit handling by the end user while not reported, cannot be excluded as a possible cause. 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.

 
Event Description

It was reported that a 3dmax mesh was found to be damaged out of the packaging. The device was not used in the case. There was no patient involvement.

 
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Brand Name3DMAX
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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5936616
MDR Text Key54276719
Report Number1213643-2016-00426
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/15/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0115311
Device LOT NumberHUAP0685
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/15/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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