MAUDE Adverse Event Report: M + C SCHIFFER GMBH MACLEANS MULTI ACTION TOOTHBRUSH; TOOTHBRUSHES

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Discomfort (2330); Choking (2464); Foreign Body In Patient (2687)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), macleans multi action toothbrush.Macleans multi action toothbrush is marketed as aquafresh in the us.

Event Description

Choking [choking].Gagging [gagging].Discomfort [discomfort]."bristles and middle section lodged in mouth"/ "bristles and middle section lodged in throat".[foreign body in gi tract].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) male patient who received gsk toothbrush (macleans multi action toothbrush) toothbrush for oral hygiene.This case was associated with a product complaint.On an unknown date, the patient started macleans multi action toothbrush (dental) at an unknown dose and frequency.On (b)(6) 2016, an unknown time after starting macleans multi action toothbrush, the patient experienced choking (serious criteria gsk medically significant), gagging, discomfort and foreign body in gi tract.On an unknown date, the patient experienced product complaint.Macleans multi action toothbrush was discontinued (dechallenge was positive).On an unknown date, the outcome of the choking, gagging, discomfort and foreign body in gi tract were recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the choking, gagging, discomfort and foreign body in gi tract to be related to macleans multi action toothbrush.Additional details, the consumer reported a complaint about the suspect product (medium).He stated that the last portion of the centre bristles tend to fall off which lead to them accumulating in his mouth, resulting in choking and gagging.He started experiencing choking/gagging after using the product on (b)(6) 2016.The consumer stated that he has two toothbrushes, one was used three times which lead to the bristles falling off, the other had been used twice and was still intact.He mentioned that he no longer wants to use the product anymore since its design is prone to this issue.Consumer confirmed he was fine at the moment.The patient reported that he recently purchased 2 macleans multi action toothbrushes, after the 3rd usage of 1 brush the centre section busted out of the brush, at the end set of bristles closer the handle end, resulting in that set of bristles and the middle section to be lodged in his mouth and throat, causing him much discomfort, yes no need to go on.The patient stated that "not being a tooth brush designer or engineer i must still make a comment after i examined the remains, i found this area to be extremely ineffective in strength design".

Manufacturer Narrative

This submission includes qa results which were inadvertently omitted from the last report submitted on 18 august 2016.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) male patient who received gsk toothbrush (macleans multi action toothbrush) toothbrush for oral hygiene.This case was associated with a product complaint.On an unknown date, the patient started macleans multi action toothbrush (dental) at an unknown dose and frequency.On (b)(6) 2016, an unknown time after starting macleans multi action toothbrush, the patient experienced choking (serious criteria gsk medically significant), gagging, discomfort and foreign body in gi tract.On an unknown date, the patient experienced product complaint.Macleans multi action toothbrush was discontinued (dechallenge was positive).On an unknown date, the outcome of the choking, gagging, discomfort and foreign body in gi tract were recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the choking, gagging, discomfort and foreign body in gi tract to be related to macleans multi action toothbrush.Additional details, the consumer reported a complaint about the suspect product (medium).He stated that the last portion of the centre bristles tend to fall off which lead to them accumulating in his mouth, resulting in choking and gagging.He started experiencing choking/gagging after using the product on (b)(6) 2016.The consumer stated that he has two toothbrushes, one was used three times which lead to the bristles falling off, the other had been used twice and was still intact.He mentioned that he no longer wants to use the product anymore since its design is prone to this issue.Consumer confirmed he was fine at the moment.The patient reported that he recently purchased 2 macleans multi action toothbrushes, after the 3rd usage of 1 brush the centre section busted out of the brush, at the end set of bristles closer the handle end, resulting in that set of bristles and the middle section to be lodged in his mouth and throat, causing him much discomfort, yes no need to go on.The patient stated that "not being a tooth brush designer or engineer i must still make a comment after i examined the remains, i found this area to be extremely ineffective in strength design".Follow up received from qa on 02 aug 2016 the qa analysis found the complaint was undetermined.Follow up received from qa on 12 aug 2016 the complaint was unsubstantiated.

• Brand Name: MACLEANS MULTI ACTION TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M + C SCHIFFER GMBH; industriestrasse 4 neustadt/wi; germany 53577 ; GM 53577
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5820742
• MDR Text Key: 50392126
• Report Number: 9615008-2016-00009
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/18/2016; 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR