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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117320
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
As reported, the 3dmax light mesh was folded and damaged prior to use. There was no reported patient injury. The subject device is being returned for evaluation. However, at this time has not been received. Based on the available information, we are unable to determine a definitive root cause for the reported event. To date this is the only reported complaint from this manufacturing lot. If/when the sample is received and evaluated, a supplemental mdr will be submitted.
 
Event Description
It was reported that on (b)(6) 2020, the 3dmax light medium right mesh was opened prior to the procedure and noted that the mesh was folded and damaged. The alleged damage was seen around the center of the mesh. The edge was damaged by the user when the mesh was grasped by forceps. The procedure was completed by using another mesh. There was no reported patient injury.
 
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Brand Name3DMAX LIGHT
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key11097627
MDR Text Key225488877
Report Number1213643-2020-20090
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117320
Device Lot NumberHUEQ0349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Yes
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: 12/30/2020 Patient Sequence Number: 1
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