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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH Back to Search Results
Catalog Number 5955450
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
Event Type  malfunction  
Manufacturer Narrative
Initial evaluation of the received sample finds that the two mesh connectors are present on the balloon with only one attached through to the mesh.There is a hole in the mesh in the location that the detached connector would have been attached.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.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 191 units released for distribution in nov, 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, during laparoscopic ventral hernia repair procedure it was noted that the ventralight st w/echo ps coil was pulled out when removed from the package prior to use.It was reported that no damage was noted to the product package.The procedure was completed using new mesh.There was no reported patient injury.
 
Manufacturer Narrative
Initial evaluation of the received sample finds that the two mesh connectors are present on the balloon with only one attached through to the mesh.There is a hole in the mesh in the location that the detached connector would have been attached.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.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 191 units released for distribution in nov, 2022.Addendum: h11: this supplemental mdr is submitted to document the sample evaluation results.Based on the sample evaluation and investigation performed, root cause is determined to be manufacturing related possibly occurring during the assembly process.Awareness notification was provided to all appropriate 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, during laparoscopic ventral hernia repair procedure it was noted that the ventralight st w/echo ps coil was pulled out when removed from the package prior to use.It was reported that no damage was noted to the product package.The procedure was completed using new mesh.There was no reported patient injury.
 
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Brand Name
VENTRALIGHT ST W/ ECHO
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 Key16818142
MDR Text Key314041023
Report Number1213643-2023-00160
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130968
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 05/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5955450
Device Lot NumberHUGX0492
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2023
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2022
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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