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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 Y500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Prolapse (2475); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
November 2018- bimonthly asr report.(b)(4).The total number of events for product classification code oto is 13.Qty 6- alyte y-mesh graft, sterile; qty 7- alyte y-mesh graft, sterile (5-pack).Sample not received.
 
Event Description
November 2018- bimonthly asr.
 
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Brand Name
ALYTE Y-MESH GRAFT
Type of Device
ALYTE 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
angela robinson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8051405
MDR Text Key126549192
Report Number1018233-2018-05247
Device Sequence Number1
Product Code OTO
UDI-Device Identifier00801741016165
UDI-Public(01)00801741016165
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
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date02/28/2014
Device Catalogue NumberY500
Device Lot NumberHUVL0168
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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