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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOBBS MEDICAL, INC. HOBBS MEDICAL MICROBIOLOGY BRUSH
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HOBBS MEDICAL, INC. HOBBS MEDICAL MICROBIOLOGY BRUSH Back to Search Results
Model Number 4310
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2023
Event Type  malfunction  
Event Description
According to the initial reporter, a microbiology brush was used on a patient for bronchoscopy.While taking the brush sample, the blue plastic tear drop tip on the distal end of the brush came off and fell into the patient's bronchus.The plastic tip was removed with suction, and no major damage was visible.
 
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Brand Name
HOBBS MEDICAL MICROBIOLOGY BRUSH
Type of Device
MICROBIOLOGY BRUSH
Manufacturer (Section D)
HOBBS MEDICAL, INC.
8 spring street
stafford springs CT 06076
Manufacturer (Section G)
HOBBS MEDICAL, INC.
8 spring street
stafford springs CT 06076
Manufacturer Contact
jennifer hodge
8 spring street
stafford springs, CT 06076
8606845875
MDR Report Key17617995
MDR Text Key321950381
Report Number1220592-2023-00004
Device Sequence Number1
Product Code FDX
UDI-Device IdentifierM84943100
UDI-PublicM84943100
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K893729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2023
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 Model Number4310
Device Catalogue Number4310
Device Lot NumberH10-22-072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/03/2023
Initial Date FDA Received08/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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