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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 MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954450
Device Problem Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2020
Event Type  Malfunction  
Manufacturer Narrative

As reported, the ventralight st mesh did not have any st coating on it. The subject device was returned for evaluation. Visual evaluation of the sample confirmed the presence of the st coating on it and is not missing as alleged. The mesh had not been hydrated and the coating has been marked with surgical ink and had become wrinkled and creased due to handling prior to the attempted use, which is not indicative of the as manufactured condition. There were no voids or separations in the coating. Based on the sample evaluation and investigation performed, the reported event of missing st coating is unconfirmed. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2020.

 
Event Description

It was reported that, during an unspecified procedure on (b)(6) 2020, when the ventralight st mesh was removed from the package, it was noted that the mesh did not have any st coating on it. As reported, the or staff did not use the mesh and used another ventralight st mesh for the case. There was no reported patient harm/injury.

 
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Brand NameVENTRALIGHT ST MESH
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 Key10958111
MDR Text Key219898134
Report Number1213643-2020-20067
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5954450
Device LOT NumberHUEP1894
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/29/2020
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: 12/07/2020 Patient Sequence Number: 1
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