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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117320
Device Problems Material Puncture/Hole (1504); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2019
Event Type  Malfunction  
Manufacturer Narrative

Visual evaluation of the sample identifies the hole/tear in the center of the mesh as reported. Based on the condition of the mesh it appears it was handled by the user in a manner that resulted in damage that contributed to the hole/tear that was identified. Folds and creases in the edge seal and mesh indicate the 3dmax was folded during handling in preparation for implantation. In the area of the damage where the hole/tear is noted it appears that the area in question was damaged from a combination of user handling stretching of the mesh and the use of a grasper. This is indicated by monofilaments that have been pulled on, resulting in the monofilaments becoming unwoven and torn at the damaged area creating the hole/tear in the mesh. There were no manufacturing anomalies noted to the sample during review. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in april, 2019. A review of the manufacturing records was performed and found that the lot was manufactured to specification.

 
Event Description

It was reported that on (b)(6) "019" a bard 3dmax light mesh was being used for a laparoscopic hernia repair. As reported prior to implant the mesh was found to have a hole. There was no injury to the patient or intervention. As reported, the packaging was inspected and reported to be intact.

 
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Brand Name3DMAX LIGHT
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 Key9087928
MDR Text Key159517740
Report Number1213643-2019-08979
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK091659
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
Report Date 09/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0117320
Device LOT NumberHUCZ1692
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/26/2019
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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