MAUDE Adverse Event Report: M + C SCHIFFER GMBH MACLEANS MILK TEETH TOOTHBRUSH; TOOTHBRUSHES

Lot Number S5237173S

Device Problem Component Falling (1105)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This gsk toothbrush is marketed as aquafresh infant training toothbrush in the u.S.

Event Description

Choking.This case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) female patient who received gsk toothbrush for drug use for unknown indication.This case was associated with a product complaint.In (b)(6) 2016, the patient started gsk toothbrush (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant).On an unknown date, the patient experienced product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking was unknown and the outcome of the product complaint was unknown.The reporter considered the choking to be related to gsk toothbrush.Additional details: after only 2 to 3 uses a bunch of bristles (clump of 3 strands) somehow fell out and became lodged in the patient's throat causing her to choke.Another bristle was coming out of the toothbrush.

Manufacturer Narrative

Report 9615008-2016-00004 is associated with (b)(4), gsk toothbrush.This gsk toothbrush is marketed as aquafresh infant training toothbrush in the us.

Event Description

Choking [choking] "the bristles then became loose and got stuck in her daughter's throat" [foreign body in pharynx] case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) female patient who received gsk toothbrush for drug use for unknown indication.This case was associated with a product complaint.In (b)(6) 2016, the patient started gsk toothbrush (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant).On an unknown date, the patient experienced product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking was unknown and the outcome of the product complaint was unknown.The reporter considered the choking to be related to gsk toothbrush.Additional details: after only 2 to 3 uses a bunch of bristles (clump of 3 strands) somehow fell out and became lodged in the patient's throat causing her to choke.Another bristle was coming out of the toothbrush.Follow-up information received on 29-mar-2016: on an unknown date, the patient started gsk toothbrush.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant), foreign body in pharynx and product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking, foreign body in pharynx and product complaint were unknown.The reporter considered the choking to be related to gsk toothbrush.It was unknown if the reporter considered the foreign body in pharynx to be related to gsk toothbrush.The mother stated that she had the toothbrush for less than a week and after using the brush 2-3 times, the bristles then became loose and got stuck in her daughter's throat.No further information was obtained as the call unexpectedly got disconnected.

Manufacturer Narrative

Report 9615008-2016-00004 is associated with (b)(4), gsk toothbrush.This gsk toothbrush is marketed as aquafresh infant training toothbrush in the us.Device qa results: the examination of the retained sample revealed that the toothbrushes are produced and released according to gsk specifications deviations.A trend analysis with same product of complaint subject shows no abnormalities.Any further review requires the claimed sample.The classification of the complaint was undetermined.No manufacturing error has been detected.

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) female patient who received gsk toothbrush for drug use for unknown indication.This case was associated with a product complaint.In (b)(6) 2016, the patient started gsk toothbrush (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant).On an unknown date, the patient experienced product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking was unknown and the outcome of the product complaint was unknown.The reporter considered the choking to be related to gsk toothbrush.Additional details: after only 2 to 3 uses a bunch of bristles (clump of 3 strands) somehow fell out and became lodged in the patient's throat causing her to choke.Another bristle was coming out of the toothbrush.Follow-up information received on 29-mar-2016: on an unknown date, the patient started gsk toothbrush.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant), foreign body in pharynx and product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking, foreign body in pharynx and product complaint were unknown.The reporter considered the choking to be related to gsk toothbrush.It was unknown if the reporter considered the foreign body in pharynx to be related to gsk toothbrush.The mother stated that she had the toothbrush for less than a week and after using the brush 2-3 times, the bristles then became loose and got stuck in her daughter's throat.No further information was obtained as the call unexpectedly got disconnected.Follow-up information received from qa on 01 april 2016.Based on the investigation findings, the complaint is not substantiated.The manufacturing site conducted their investigation using macleans milk teeth toothbrush 0-3 years as the assumed product.However, note that the reporter only stated that they purchase one of our 0-2 year old toothbrushes.

Manufacturer Narrative

9615008-2016-00004 is associated with argus case (b)(4), macleans milk teeth toothbrush.Macleans milk teeth toothbrush is marketed as aquafresh infant training toothbrush in the us.Device qa results on (b)(6) 2016: the examination of the retained sample revealed that the toothbrushes are produced and released according to gsk specifications deviations.A trend analysis with same product of complaint subject shows no abnormalities.Any further review requires the claimed sample.The classification of the complaint was undetermined.No manufacturing error has been detected.Device qa results on (b)(6) 2016: root cause analysis: the analysis includes visual and microscopic inspection, view of product review.Anchor position, tuft hole filling, cut, filament diameter and end rounding are correct.Tuft retention force is monitored and documented by production control in each sift.Deviations are not documented.The microscopic inspection showed traces of squashes at the filament ends.This damage is obviously caused by biting on the filaments.Individual filaments of bundle can thus be extracted during the brushing.This is not anxious to avoid by this technology.It is most likely that the toothbrush was manufactured according to current specifications.This complaint is not due to production error.Corrective actions: none.Classification: unsubstantiated.

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) female patient who received gsk toothbrush toothbrush for drug use for unknown indication.This case was associated with a product complaint.In (b)(6) 2016, the patient started gsk toothbrush (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant).On an unknown date, the patient experienced product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking was unknown and the outcome of the product complaint was unknown.The reporter considered the choking to be related to gsk toothbrush.Additional details: after only 2 to 3 uses a bunch of bristles (clump of 3 strands) somehow fell out and became lodged in the patient's throat causing her to choke.Another bristle was coming out of the toothbrush.Follow-up information received on 29-mar-2016: on an unknown date, the patient started gsk toothbrush.On an unknown date, an unknown time after starting gsk toothbrush, the patient experienced choking (serious criteria gsk medically significant), foreign body in pharynx and product complaint.Gsk toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking, foreign body in pharynx and product complaint were unknown.The reporter considered the choking to be related to gsk toothbrush.It was unknown if the reporter considered the foreign body in pharynx to be related to gsk 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 mother stated that she had the toothbrush for less than a week and after using the brush 2-3 times, the bristles then became loose and got stuck in her daughter's throat.No further information was obtained as the call unexpectedly got disconnected.Follow-up information received from qa on 01 (b)(6) 2016 based on the investigation findings, the complaint is not substantiated.The manufacturing site conducted their investigation using macleans milk teeth toothbrush 0-3 years as the assumed product.However, note that the reporter only stated that they purchase one of our 0-2 year old toothbrushes.Follow up was received on 13 june 2016 from quality assurance department.This case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) female patient who received gsk toothbrush (macleans milk teeth toothbrush) toothbrush (batch number (b)(4), expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.In (b)(6) 2016, the patient started macleans milk teeth toothbrush (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting macleans milk teeth toothbrush, the patient experienced choking (serious criteria gsk medically significant), foreign body in pharynx and product complaint.Macleans milk teeth toothbrush was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choking, foreign body in pharynx and product complaint were unknown.It was unknown if the reporter considered the choking and foreign body in pharynx to be related to macleans milk teeth toothbrush.Additional details to follow up, based on the investigation findings the complaint was not substantiated.It was also confirmed that the suspect product was macleans milk teeth toothbrush.

• Brand Name: MACLEANS MILK TEETH 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: 5536640
• MDR Text Key: 41525426
• Report Number: 9615008-2016-00004
• 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,Followup
• Report Date: 03/22/2016

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
• Device Lot Number: S5237173S
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/11/2016; 04/19/2016; 06/28/2016
• 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: 16 MO