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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
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MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 6.0PLC
Medical Device Problem Codes Air Leak (1008); Inflation Problem (1310)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/08/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Medtronic received a report the tracheostomy tube had a cuff leak.Medtronic is requesting additional information regarding the circumstances of the event.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SHILEY
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX  32590
MDR Report Key6679822
Report Number2936999-2017-05304
Device Sequence Number10992794
Product Code JOH
UDI-Device Identifier20884522029053
UDI-Public20884522029053
Combination Product (Y/N)N
Initial Reporter CountryMX
PMA/510(K) Number
K955680
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/28/2021
Device Model Number6.0PLC
Device Catalogue Number6.0PLC
Device Lot Number16C0858JZX
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/12/2017
Supplement Date Received by Manufacturer06/12/2017
Initial Report FDA Received Date06/29/2017
Supplement Report FDA Received Date09/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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