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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)
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MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number 18875
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Localized Skin Lesion (4542); Unintended Extubation (4564)
Date of Event 04/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, after a week of intubation, severe swelling and blistering of the trachea walls where cuff was inflated was found.It was reported that the patient had allergy to sulfa.The patient had to be trached because of the patient's reaction to the ett (endotracheal tube).
 
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Brand Name
SHILEY
Common Device Name
TUBE, TRACHEAL (W/WO CONNECTOR)
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX  32590
MDR Report Key11739959
Report Number2936999-2021-00381
Device Sequence Number3091803
Product Code BTR
UDI-Device Identifier10884521032538
UDI-Public10884521032538
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K090352
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/28/2021
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 Model Number18875
Device Catalogue Number18875
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date04/28/2021
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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