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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALYTE Y-MESH GRAFT

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C.R. BARD, INC. (COVINGTON) -1018233 ALYTE Y-MESH GRAFT Back to Search Results
Catalog Number Y100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Anxiety (2328); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative
The product family for this women¿s health product is unknown; and therefore, the appropriate labeling /product documents for review could not be determined. Sample not received.
 
Event Description
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, suffering, disability and impairment. The litigation does not specifically state which product was used on the patient therefore an unknown complaint is being entered.
 
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Brand NameALYTE Y-MESH GRAFT
Type of DeviceALYTE Y-MESH GRAFT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key12373873
MDR Text Key268351587
Report Number1018233-2021-80064
Device Sequence Number1
Product Code OTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/10/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Catalogue NumberY100
Device Lot NumberHUYB1183
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Device Age4 MO
Event Location Hospital
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2014
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: 08/26/2021 Patient Sequence Number: 1
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