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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
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MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number TTH
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the unit tape was attached on one side only.There was no patient involvement.
 
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Brand Name
SHILEY
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
MALLINCKRODT MEDICAL
cornamaddy
athlone 3810
MDR Report Key9617168
Report Number8020889-2020-00005
Device Sequence Number2677068
Product Code JOH
UDI-Device Identifier10884522042994
UDI-Public10884522042994
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K962173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/01/2024
Device Model NumberTTH
Device Catalogue NumberTTH
Device Lot Number201907389X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/09/2020
Supplement Date Received by Manufacturer01/09/2020
Initial Report FDA Received Date01/22/2020
Supplement Report FDA Received Date02/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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