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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 MESH W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033); Reaction (2414)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
A sample mesh has been provided to the medical facility for reactivity testing, at this time it is unknown when/if the testing will be performed. Based on the information provided no conclusion can be made, as to what is causing the patient's reported reaction. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Allergic reaction is identified in the adverse reactions section of the instructions-for-use as a possible complication. Should additional information be provided a supplemental emdr will be submitted. Remains implanted.
 
Event Description
It was reported that following the implant of a bard ventralight st mesh the patient experienced a possible allergic reaction to the mesh.
 
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Brand NameVENTRALIGHT ST MESH 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 Key8778341
MDR Text Key150678133
Report Number1213643-2019-05965
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2020
Device Catalogue Number5955600
Device Lot NumberHUCU0523
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2018
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: 07/10/2019 Patient Sequence Number: 1
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