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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5954680
Device Problems Product Quality Problem (1506); Material Separation (1562); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation in process. A review of the manufacturing records was performed. No manufacturing issues associated to the reported event were found in the reviewed lot. All process steps were completed per manufacturing procedures and inspection procedures. There were no manufacturing abnormalities that may have contributed to this complaint. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in march, 2018 a supplemental emdr will be submitted once the evaluation has been completed.
 
Event Description
It was reported that on (b)(6) 2018 while preparing a davol ventralight st mesh for use it was noted that, "it appears a small part of the (hydrogel) barrier has been compromised and you can see through it. " the mesh was not implanted. A second piece of davol ventralight st mesh was used to complete the case without issue. As reported the problem resulted in an inconsequential delay, there was no impact to the patient.
 
Manufacturer Narrative
This is an addendum to the intial emdr to document the completion and results of the sample evaluation. As reported while preparing the ventralight st mesh for use it was noted that, "it appears a small part of the (hydrogel) barrier has been compromised and you can see through it. " visible on the hydrogel coated side of the device is an area that looks different from the rest of the sample. This area does not have the same glossy finish present as the rest of the surface of sample. Further evaluation confirms the presence of hydrogel, however the amount of hydrogel that is present is thinner than the amount applied to the rest of the surface. This condition would be considered a discrepancy per the inspection requirements. Due to this finding additional operator training has been conducted. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in march, 2018.
 
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Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7480699
MDR Text Key107199156
Report Number1213643-2018-01267
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Catalogue Number5954680
Device Lot NumberHUCN1774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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