MAUDE Adverse Event Report: SHUMEI INDUSTRIAL (HEBEI) CO LTD DR. BEST JUNIORZAHN VIBRATION ZAHNBÜRSTE; TOOTHBRUSHES

Lot Number E0240H

Device Problem Product Quality Problem (1506)

Patient Problem Vomiting (2144)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Probably swallowed a few of them(bristels) [accidental device ingestion], vomited [vomiting].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a (b)(6)-year-old female patient who received gsk toothbrush (dr.Best juniorzahn vibration zahnbürste) toothbrush (batch number e0240h, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On (b)(6) 2021, the patient started dr.Best juniorzahn vibration zahnbürste.On (b)(6) 2021, 7 days after starting dr.Best juniorzahn vibration zahnbürste, the patient experienced foreign body in throat (serious criteria gsk medically significant) and vomiting.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and product complaint.On (b)(6) 2021, the outcome of the foreign body in throat and vomiting were recovered/resolved.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, accidental device ingestion and vomiting to be related to dr.Best juniorzahn vibration zahnbürste.Additional information: the case was reported by consumer via call center representative on 03 may 2021.The consumer reported that "i have a complaint about a dr.Best junior vibration toothbrush.My daughter has been using the toothbrush for 5 days and this morning bristles have fallen out of it.She probably swallowed a few of them.This morning the daughter got the bristles in the throat and vomited.We had a day of work loss, what i am to get as compensation.I only send back the toothbrush after i get compensation.Otherwise, i will consult a lawyer." follow up information received from quality assurance department on 12 may 2021 for the issue (b)(4) for batch number e0240h.The batch e0240h which was provided to the cr hub agent is invalid.The physical sample was requested by the cr hub agent, but the consumer is only willing to return the sample when the product was reimbursed 05/03/2021 al.2021,05 12 06:07:00.No defect sample or pictures available for further confirmation and investigation till now.After reviewed the production and inspection records of this batch, no similar issue was found in the process.After further review the complaint history of this batch product, no complaint has been fed back.

• Brand Name: DR. BEST JUNIORZAHN VIBRATION ZAHNBÜRSTE
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): SHUMEI INDUSTRIAL (HEBEI) CO LTD; zhou city, ; CH
• MDR Report Key: 11889020
• MDR Text Key: 266705603
• Report Number: 3006536571-2021-00003
• 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
• Report Date: 05/03/2021

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: E0240H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/26/2021
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR