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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 5954610
Device Problem Biocompatibility (2886)
Patient Problems Edema (1820); Urticaria (2278); Reaction (2414)
Event Date 08/17/2020
Event Type  Injury  
Manufacturer Narrative
Based on the information provided to date, no conclusion can be made regarding a correlation between the patient's postoperative course and the bd/bard device used to treat the patient. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Additional information has been requested including the date of implant and product lot number. The instructions-for-use (ifu) supplied with the device identifies allergic reaction as a possible complication. Should additional information be provided, a supplemental emdr will be submitted. Remains implanted.
 
Event Description
It was reported that following implant of a ventralight st, the patient had adverse effects like allergy type edema of lips, neck and was treated with solumedrol (corticosteroid) by the surgeon. It had evolved and turned into hives on upper and lower limbs. There was no increase in temperature and blood culture was negative.
 
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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 Key10553445
MDR Text Key207524560
Report Number1213643-2020-20002
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5954610
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 Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/18/2020 Patient Sequence Number: 1
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