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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 0117311
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Manufacturer Narrative
It is alleged that one side of the 3dmax light mesh package was found to be unsealed when opened for a case.The subject device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.If/when the sample is returned and evaluated and/or additional information is provided, a supplemental mdr will be submitted.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 for this manufacturing lot of 1183 units released for distribution in february 2021.Not returned.
 
Event Description
As reported, during a totally extraperitoneal (tep) hernia repair procedure on (b)(6) 2021, while opening the sterile package of the bard/davol 3dmax light mesh out of the box, the mesh fell on the ground.It was reported that the package is usually opened from one side, but the other side was already open (not sealed), so the device fell on the ground.As reported, another device was used to complete the procedure and there was no reported patient injury.
 
Event Description
As reported, during a totally extraperitoneal (tep) hernia repair procedure on (b)(6) 2021, while opening the sterile package of the bard/davol 3dmax light mesh out of the box, the mesh fell on the ground.It was reported that the package is usually opened from one side, but the other side was already open (not sealed), so the device fell on the ground.As reported, another device was used to complete the procedure and there was no reported patient injury.
 
Manufacturer Narrative
It is alleged that one side of the 3dmax light mesh package was found to be unsealed when opened for a case.The subject device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.If/when the sample is returned and evaluated and/or additional information is provided, a supplemental mdr will be submitted.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 for this manufacturing lot of 1183 units released for distribution in february 2021.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.Evaluation of the sample finds that the packaging of the product is opened at the bottom manufacturing seal, as reported and the top chevron seal is also opened from attempted opening by the user.Inspection of the entire pouch and sealing area found that good adhesive transfer is evident and shows the pouch was sealed correctly and the pouch integrity was intact.Examination of the seal confirms there was no breach to the package prior to opening.Based on the sample evaluation and investigation performed, the root cause of the reported event is that after being distributed, the pouch may have been opened and returned to the unit carton at some point prior to the attempted use.Sample evaluated.
 
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Brand Name
3DMAX LIGHT
Type of Device
SURGICAL 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 Key13026701
MDR Text Key282491277
Report Number1213643-2021-20473
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031038
UDI-Public(01)00801741031038
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0117311
Device Lot NumberHUEX1699
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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