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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 0117321
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Manufacturer Narrative
Based on the information provided and not having the sample to evaluate, no conclusion can be made.As reported the sample is being returned, however at this time has not been received.No lot number has been provided; therefore, a review of the manufacturing records is not possible.If/when the sample is received a semdr will be submitted to document the sample evaluation results.Not returned.
 
Event Description
As reported on (b)(6) 2022, prior to use, of a 3dmax light mesh a foreign material like hair was found.There was no reported patient injury.
 
Event Description
As reported on 13-oct-2022, prior to use, of a 3dmax light mesh a foreign material like hair was found.There was no reported patient injury.
 
Manufacturer Narrative
Based on the information provided and not having the sample to evaluate, no conclusion can be made.As reported the sample is being returned, however at this time has not been received.No lot number has been provided; therefore, a review of the manufacturing records is not possible.If/when the sample is received a semdr will be submitted to document the sample evaluation results.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.The subject device was returned for evaluation.Visual evaluation of the returned sample (inner clamshell tray) confirmed the presence of foreign material (human hair like) inside of the product inner clamshell as reported.The reported/found condition may have originated at the manufacturing area prior to sealing of the inner package.Based on the sample evaluation and investigation performed, root cause is determined to be manufacturing related.Awareness training was provided to appropriate manufacturing personnel.Note: section a through f - the information provided by bd 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 bd.H3 other text : 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 Key15721834
MDR Text Key304365879
Report Number1213643-2022-00702
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031069
UDI-Public(01)00801741031069
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 Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0117321
Device Lot NumberHUGN0662
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2022
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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