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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR
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ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS 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 12/11/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number:1627487-2020-49144.It was reported that the anchor sites were protruding and bothering the patient.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the anchor sites were revised.Issue resolved.
 
Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .
 
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Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SCS ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11074083
MDR Text Key223705384
Report Number1627487-2020-49143
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 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/14/2021
Device Model Number1192
Device Catalogue Number1192
Device Lot Number6762035
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS ANCHOR
Patient Outcome(s) Other;
Patient Weight52
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