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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 0115321
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
As reported, the 3dmax mesh device is being returned for evaluation. However, at this time has not been received. A photo of the subject device was provided which shows an opened inner pouch containing the protective blister tray. Note the 3dmax mesh is contained in the blister tray. Based on the information available, no conclusion can be made at this time. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in september, 2019. The warnings section of the instructions-for-use supplied with the states: "this device is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use. " if/when the sample is received and evaluated, a supplemental emdr will be submitted.
 
Event Description
It was reported that, on (b)(6) 2020, when the surgeon was about to place a 3dmax mesh intraoperatively, it was noted that the inner package was found to be damaged while opening. It was suspected that the product had a quality problem. The product was not used during the operation and there was no delay in the procedure. There was no reported patient injury.
 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10442255
MDR Text Key204016740
Report Number1213643-2020-07709
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0115321
Device Lot NumberHUDU1960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2019
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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