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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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NULL TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Lot Number 4144617
Device Problem Leak/Splash (1354)
Patient Problems Airway Obstruction (1699); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  Injury  
Event Description
It was reported the balloon had a hole in it.Patient had to be re-intubated.No patient injury was reported.
 
Manufacturer Narrative
Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
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Brand Name
TRACHEOSTOMY TUBE
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key13156525
MDR Text Key286372564
Report Number3012307300-2022-00071
Device Sequence Number1
Product Code JOH
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/27/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number4144617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/10/2021
Initial Date FDA Received01/04/2022
Supplement Dates Manufacturer Received04/21/2023
04/21/2023
Supplement Dates FDA Received02/28/2022
04/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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