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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 Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/04/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, prior to use, the device's holder was found torn in the middle upon opening the package.The customer indicated no patient involvement.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, prior to use, the device's holder was found torn in the middle upon opening the package.The longer length of the strap was torn in the middle.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 Key7443773
Report Number8020889-2018-00047
Device Sequence Number16401576
Product Code JOH
UDI-Device Identifier10884521070455
UDI-Public10884521070455
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,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/28/2019
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 Model NumberTTH
Device Catalogue NumberTTH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Initial Date Received by Manufacturer 04/04/2018
Supplement Date Received by Manufacturer03/06/2019
Initial Report FDA Received Date04/19/2018
Supplement Report FDA Received Date03/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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