MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3710PROVITALITYMODELD100.413.1; TOOTHBRUSH, POWERED

Model Number D100.413.1

Device Problem Break (1069)

Patient Problems Burn(s) (1757); Laceration(s) (1946); Scarring (2061)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed due to an alleged fire incident that we could not investigate so far.We are reporting to the fda out of an abundance of caution.The product has been requested and an investigation will be conducted upon its arrival.

Event Description

Burn on left hand, forearm, feet [thermal burn].Toothbrush exploded [device physical property issue].Case description: consumer contacted via e-mail and stated that his toothbrush exploded while on the charger in his bathroom.No serious injury was reported.Follow-up: the fire started at the charger.

Manufacturer Narrative

02-jul-2020 product investigation results: product return was received and investigated.Investigation results showed that all product components are internally intact despite melting from the outside.No failure of the product could be identified explaining alleged fire incident.

Event Description

Burn on left hand, forearm, feet [thermal burn], cuts both feet [skin laceration], scars [scar], toothbrush exploded [device physical property issue], toothbrush started on fire at the base of the charger [device catching fire].Case description: consumer contacted via e-mail and stated that his toothbrush exploded while on the charger in his bathroom.No serious injury was reported.Follow-up: the fire started at the charger.Follow-up: the toothbrush started on fire at the base of the charger.Follow-up: the cleaning center melted into a plastic puddle on top of the cabinet.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3710PROVITALITYMODELD100.413.1
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 10118933
• MDR Text Key: 194387137
• Report Number: 3000302531-2020-00092
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D100.413.1
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADDERALL; BIKTARVY; CITALOPRAM; HIV MEDICATION; HIV MEDICATION; METOPROLOL
• Patient Age: 32 YR
• Patient Weight: 91