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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALEX ST; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALEX ST; SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Manufacturer Narrative
As reported, upon opening a ventralex st mesh a hair was present in/on the packaging.Returned was the product outer carton, which contained the inner foil pouch, inside was the ventralex st mesh contained within the inner tyvek protective sleeve.Initial review finds visible blood contamination on the mesh from handling.The foreign material (hair) was found on the inside of the inner tyvek protective sleeve.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.
 
Event Description
As reported, upon opening the package of the ventralex st mesh during the procedure, a hair was noted in/on the packaging.As reported, the mesh was not used for the procedure.There was no reported patient injury.
 
Manufacturer Narrative
As reported, upon opening a ventralex st mesh a hair was present in/on the packaging.Returned was the product outer carton, which contained the inner foil pouch, inside was the ventralex st mesh contained within the inner tyvek protective sleeve.Initial review finds visible blood contamination on the mesh from handling.The foreign material (hair) was found on the inside of the inner tyvek protective sleeve.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Visual evaluation identified foreign material (hair) inside of the inner tyvek product envelope as reported.Review of the manufacturing process indicates the possibility of a manufacturing related cause for the reported/found condition.However, visual examination of the returned sample presented the presence of blood/contamination, showing the product unit had been manipulated by end user.This could indicate the possibility that the foreign material may have been introduced at time of use.As such the reported event is confirmed, however a definitive root cause cannot be determined.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april, 2022.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.
 
Event Description
As reported, upon opening the package of the ventralex st mesh during the procedure, a hair was noted in/on the packaging.As reported, the mesh was not used for the procedure.There was no reported patient injury.
 
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Brand Name
VENTRALEX ST
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 Key15168808
MDR Text Key297428373
Report Number1213643-2022-00566
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031489
UDI-Public(01)00801741031489
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2023
Device Catalogue Number5950008
Device Lot NumberHUGN1781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2022
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2022
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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