Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MACLEANS MULTI ACTION TOOTHBRUSH; TOOTHBRUSHES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MACLEANS MULTI ACTION TOOTHBRUSH; TOOTHBRUSHES Back to Search Results
Lot Number M42650801, S0279571S A
Device Problem Product Quality Problem (1506)
Patient Problem Choking (2464)
Event Type  Injury  
Manufacturer Narrative
Argus case id : (b)(4).
 
Event Description
The bristles came loose and i choked myself [choking].I couldn't breathe for about more than a minute / i could have died since i suffocated for more than a minute [suffocation].I was dizzy for a few minutes [dizziness].I was very red in the face [red face].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a male patient who received gsk toothbrush (macleans multi action toothbrush) toothbrush (batch number m42650801, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started macleans multi action toothbrush.On an unknown date, an unknown time after starting macleans multi action toothbrush, the patient experienced choking (serious criteria gsk medically significant), suffocation (serious criteria gsk medically significant) and product complaint.The action taken with macleans multi action toothbrush was unknown.On an unknown date, the outcome of the choking, suffocation and product complaint were unknown.The reporter considered the choking and suffocation to be related to macleans multi action toothbrush.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information : the adverse event information was received via call centre representative on 01 jun 2021.The consumer reported that, " i have a big issue with macleans multi action toothbrush soft.I bought it probably last (b)(6).The bristles came loose and i choked myself wherein i couldn't breathe for about more than a minute.I could have died since i suffocated for more than a minute.I need to talk to somebody about better compensation.If we don't agree, i will contact the authorities about this".Follow up information was received on 04 jun 2021.The consumer reported that, "i'll just repeat myself about this case, i bought mclean's toothbrush approx.2-3 weeks ago, from , to try this soft multi action toothbrush.I still have other toothbrushes which i use ( care dental & colgate etc.).However, i bought this toothbrush thinking this was a [?]superior' product which i never used before etc.A few days ago i've tried this new product but the bristles in the brush came loose and stuck in my throat and i couldn't breathe for over 1 (one) minute.In that moments i felt i was going to die.Somehow, i suppose i was lucky, i've managed to pull out those bristles stuck in my throat.I was very red in the face and i couldn't believe that someone could die from brushing their teeth with mclean's toothbrush.I've never experience this before.I wonder if anyone had this [?]experience' before me i'm not sure if this product (mclean's) is sold world wide etc.If this is the case, how many people are vulnerable to the [?]bristiles of death' now, you've asked me to fill out some form and the doctor to give you some report.Well i couldn't tell the doctor (yet) what has happened that i was dizzy for a few minutes and then i've started breathing [?]normally".Again i'll mention to my doctor what has happened, but i don't see what's relevant to this action at this moment etc.I believe if this get out of hand many people around the world will [?]benefit' from knowing that mclean's products are faulty/substandard and maybe others will take action as well.Waiting for your reply".
 
Manufacturer Narrative
Argus case: (b)(4).
 
Manufacturer Narrative
Argus case id: (b)(4).
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a male patient who received gsk toothbrush (macleans multi action toothbrush) toothbrush (batch number m42650801, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started macleans multi action toothbrush.On an unknown date, an unknown time after starting macleans multi action toothbrush, the patient experienced choking (serious criteria gsk medically significant), suffocation (serious criteria gsk medically significant) and product complaint.The action taken with macleans multi action toothbrush was unknown.On an unknown date, the outcome of the choking, suffocation and product complaint were unknown.The reporter considered the choking and suffocation to be related to macleans multi action toothbrush.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information : the adverse event information was received via call centre representative on (b)(6)2021.The consumer reported that, " i have a big issue with macleans multi action toothbrush soft.I bought it probably last (b)(6).The bristles came loose and i choked myself wherein i couldn't breathe for about more than a minute.I could have died since i suffocated for more than a minute.I need to talk to somebody about better compensation.If we don't agree, i will contact the authorities about this".Follow up information was received on 04 jun 2021.The consumer reported that, "i'll just repeat myself about this case, i bought mclean's toothbrush approx.2-3 weeks ago, from , to try this soft multi action toothbrush.I still have other toothbrushes which i use ( care dental & colgate etc.).However, i bought this toothbrush thinking this was a superior' product which i never used before etc.A few days ago i've tried this new product but the bristles in the brush came loose and stuck in my throat and i couldn't breathe for over 1 (one) minute.In that moments i felt i was going to die.Somehow, i suppose i was lucky, i've managed to pull out those bristles stuck in my throat.I was very red in the face and i couldn't believe that someone could die from brushing their teeth with mclean's toothbrush.I've never experience this before.I wonder if anyone had this experience' before me i'm not sure if this product (mclean's) is sold world wide etc.If this is the case, how many people are vulnerable to the bristiles of death' now, you've asked me to fill out some form and the doctor to give you some report.Well i couldn't tell the doctor (yet) what has happened that i was dizzy for a few minutes and then i've started breathing normally".Again i'll mention to my doctor what has happened, but i don't see what's relevant to this action at this moment etc.I believe if this get out of hand many people around the world will benefit' from knowing that mclean's products are faulty/substandard and maybe others will take action as well.Waiting for your reply".Follow-up information was received on 17 jun 2021 from quality assurance (qa) department regarding complaint (b)(4) and (b)(4).Further investigation is not possible without receiving the batch number or complaint sample.This complaint has been logged and will be evaluated and present in the monthly complaint review process.On the basis of the above the complaint is considered as closed.Complaint was concluded as unsubstantiated.Follow up information: follow-up information was received on 2 jul 2021 from quality assurance (qa) department regarding complaint (b)(4) and (b)(4) as well as the batch number is added as s0279571s a.The microscopic inspection of claimd samples is not possible.Review of relevant packaging batch records are done.The toothbrush was manufactured according to current specifications.No recall has been started by this article.This complaint is not due to production error.Complained is concluded as unsubstantiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MACLEANS MULTI ACTION TOOTHBRUSH
Type of Device
TOOTHBRUSHES
MDR Report Key12024133
MDR Text Key268037650
Report Number9615008-2021-00014
Device Sequence Number1
Product Code EFW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberM42650801, S0279571S A
Was Device Available for Evaluation? No
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-