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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/31/2022
Event Type  malfunction  
Event Description
As reported on (b)(6) 2022 prior to opening the 3dmax light mesh clam shell tray a foreign material (hair like), was noted in the sterile product packaging.Another device was used to complete the laparoscopic inguinal hernia repair (tapp) procedure.There was no reported patient injury.
 
Manufacturer Narrative
The physical sample was not provided for review; however, photos of the sample were provided.Initial review of the photos confirms the presence of a foreign material (appears to be hair) within the inner clam shell tray.At this time, the investigation is ongoing, and root cause has not been established.A supplemental emdr will be submitted upon completion of the investigation.Review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 679 units released for distribution in may 2022.Not returned.
 
Manufacturer Narrative
The physical sample was not provided for review; however, photos of the sample were provided.Initial review of the photos confirms the presence of a foreign material (appears to be hair) within the inner clam shell tray.At this time, the investigation is ongoing, and root cause has not been established.A supplemental emdr will be submitted upon completion of the investigation.Review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may 2022.Addendum: this supplemental mdr is submitted to document the completion of the photo evaluation.Evaluation of the photo provided confirms there is hair like foreign material present within the clam shell tray.Based on the photo 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.
 
Event Description
As reported on (b)(6) 2022 prior to opening the 3dmax light mesh clam shell tray a foreign material (hair like), was noted in the sterile product packaging.Another device was used to complete the laparoscopic inguinal hernia repair (tapp) procedure.There was no reported patient injury.
 
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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 Key15835408
MDR Text Key304361843
Report Number1213643-2022-00755
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031052
UDI-Public(01)00801741031052
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 01/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0117320
Device Lot NumberHUGR1565
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2022
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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