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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX LARYNGOSCOPE BLADES INTUBATION; LARYNGOSCOPE, RIGID

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX LARYNGOSCOPE BLADES INTUBATION; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 2970.150.20
Device Problems Structural Problem (2506); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Other, other text: this mdr was generated under protocol b10010116, 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.D4: udi information is unknown.G5: premarket (510k) number is unknown.
 
Event Description
It was reported that the customer passed the fiber optic through the blade in an incorrect orientation, but the fiber optic was able to be attached to the blade somehow.No patient injury was reported.
 
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Brand Name
PORTEX LARYNGOSCOPE BLADES INTUBATION
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16827240
MDR Text Key314130936
Report Number3012307300-2023-04694
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/27/2023
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
Device Operator Health Professional
Device Catalogue Number2970.150.20
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/21/2023
Initial Date FDA Received04/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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