• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955800
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
The sample was returned for evaluation. Visual evaluation noted the product carton is crushed in on the back side which resulted in a tear/hole in the carton. A visible tear was found in the inner sterile foil pouch. The tear in the foil pouch corresponds with the damage to the product carton. The damage to the product carton occurred from an outside impact going into the foil pouch resulting in a breach of the sterile barrier. The condition of the carton is not indicative of the as shipped condition and would have been discovered prior to distribution. Based on the sample evaluation and the investigation performed, the root cause is damage occurring in transit/handling after leaving the distribution center. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in december, 2020. Note, the date of event provided is a best estimate based on the date of awareness of the reported event.
 
Event Description
As reported, when the materials manager was stocking inventory, there was damage noted to the product carton of a bard/davol ventralight st mesh w/ echo ps. As reported, the person who received the product in, states there was no damage noted to the outer shipping box during receipt, but the product carton inside the outer shipping box was noted to have a hole. There was no reported patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL 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 Key11799323
MDR Text Key255839474
Report Number1213643-2021-20109
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031779
UDI-Public(01)00801741031779
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2022
Device Catalogue Number5955800
Device Lot NumberHUEX0976
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
-
-