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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOMIMED INC BOMIMED FIBER OPTICE DISPOSABLE LARYNGOSCOPE BLADE
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BOMIMED INC BOMIMED FIBER OPTICE DISPOSABLE LARYNGOSCOPE BLADE Back to Search Results
Model Number MILLER 00
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
Matter occurred and reported in (b)(6).
 
Event Description
After intubation, while et tube was being secured to patient, rt noticed a small piece of plastic (fiberoptic light channel) coming out of patient's mouth.No harm to the patient as the piece was retrieved without complication.
 
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Brand Name
BOMIMED FIBER OPTICE DISPOSABLE LARYNGOSCOPE BLADE
Type of Device
DISPOSABLE LARYNGOSCOPE BLADE
Manufacturer (Section D)
BOMIMED INC
1-100 irene street
winnipeg, manitoba R3T 4 E1
CA  R3T 4E1
Manufacturer (Section G)
SCOPE MECICAL DEVICES PRIVATE LIMITED
1888-b/10, baldev nagar
ambala city 13400 7
IN   134007
Manufacturer Contact
trina friesen
1-100 irene street
winnipeg, manitoba R3T 4-E1
CA   R3T 4E1
MDR Report Key10743337
MDR Text Key214808153
Report Number3003213883-2020-00001
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Administrator/Supervisor
Remedial Action Replace
Type of Report Initial
Report Date 06/29/2020
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 NumberMILLER 00
Device Catalogue NumberOL-33300
Device Lot Number1318
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/05/2020
Initial Date FDA Received10/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
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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