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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING MASK BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING MASK BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number 15245
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
Event Type  malfunction  
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Brand NamePORTEX ANESTHESIA BREATHING MASK
Type of DeviceBREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
2-12-12, kitanagase-omotemachi
minneapolis, MN 55442
MDR Report Key15261849
Report Number3012307300-2022-15710
Device Sequence Number1
Product Code CAI
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
Type of Report Initial
Report Date 08/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number15245
Device Lot Number211213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2022
Was the Report Sent to FDA? No
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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