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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR
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ABBOTT MEDICAL SWIFT-LOCK ANCHOR Back to Search Results
Model Number 1192
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Discomfort (2330)
Event Date 06/18/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-32264.It was reported the patient experienced discomfort at the anchor site.As a result, surgical intervention occurred on (b)(6) 2020 wherein the anchors were relocated to address the issue.
 
Manufacturer Narrative
The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.
 
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Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SWIFT-LOCK ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10732282
MDR Text Key212970571
Report Number1627487-2020-32265
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05414734400671
UDI-Public05414734400671
Combination Product (y/n)N
PMA/PMN Number
K092371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/18/2021
Device Model Number1192
Device Catalogue Number1192
Device Lot Number6803434
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SWIFT-LOCK ANCHOR; SWIFT-LOCK ANCHOR
Patient Outcome(s) Other;
Patient Weight86
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