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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST® ADJUSTABLE SINGLE-INCISION SLING
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C.R. BARD, INC. (COVINGTON) -1018233 AJUST® ADJUSTABLE SINGLE-INCISION SLING Back to Search Results
Catalog Number BRD705SI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The total number of events for product classification code pah is (b)(4).Qty 5- ajust adjustable single incision sling (5-pack), qty 20- ajust adjustable single incision sling (single).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Sample not returned.
 
Event Description
(b)(6) 2017 asr.
 
Manufacturer Narrative
(b)(4).Original reporting time frame january 1, 2017 through february 28, 2017.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
(b)(4).Original reporting time frame january 1, 2017 through february 28, 2017.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
Exemption e2013025.Original reporting time frame (b)(6) 2017 through (b)(6) 2017.
 
Manufacturer Narrative
Exemption e2013025.Original reporting time frame january 1, 2017 through february 28, 2017.
 
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Brand Name
AJUST® ADJUSTABLE SINGLE-INCISION SLING
Type of Device
AJUST® ADJUSTABLE SINGLE-INCISION SLING
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
lot #1, road #3, km 79.7
covington GA 30014
MDR Report Key6405699
MDR Text Key69994628
Report Number1018233-2017-01105
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
PMA/PMN Number
K092607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/30/2013
Device Catalogue NumberBRD705SI
Device Lot NumberHUVE1693
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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