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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOMIMED BOMIMED; LARYNGOSCOPE BLADE
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BOMIMED BOMIMED; LARYNGOSCOPE BLADE Back to Search Results
Model Number MAC 4
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2019
Event Type  malfunction  
Manufacturer Narrative
Upon preliminary review of the images provided, bomimed suspects the blade to be missing the light rod which transmits the light to the tip of the blade.Bomimed is waiting to hear from the customer to confirm if the light rod was completely missing or fell out of the blade and was in the products peel pouch packaging.
 
Event Description
The blade was pulled to be used in a code blue and it had no light source when pulled for use.
 
Manufacturer Narrative
Upon preliminary review of the images provided, bomimed suspects the blade to be missing the light rod which transmits the light to the tip of the blade.Bomimed is waiting to hear from the customer to confirm if the light rod was completely missing or fell out of the blade and was in the products peel pouch packaging.
 
Event Description
The blade was pulled to be used in a code blue and it had no light source when pulled for use.
 
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Brand Name
BOMIMED
Type of Device
LARYNGOSCOPE BLADE
Manufacturer (Section D)
BOMIMED
1-100 irene street
winnipeg, R3T 4 E1
CA  R3T 4E1
MDR Report Key9210498
MDR Text Key217161320
Report Number3003213883-2019-00001
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAC 4
Device Catalogue NumberOL-3314
Device Lot Number4717
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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