FDA Adverse Event
Injury
Summary report: N
REPLACEMENT BRUSH HEADS
MDR report key: 8758051
·
Received July 1, 2019
Report
- Report Number
- MW5087790
- Event Type
- Injury
- Date Received
- July 1, 2019
- Date of Event
- May 25, 2019
- Report Date
- May 28, 2019
- Manufacturer
- B. BRAUN / PROCTER & GAMBLE CO.
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HELLO, I BOUGHT REPLACEMENT BRUSHES FOR MY ORAL B. BRAUN ELECTRIC TOOTHBRUSH A FEW MONTHS AGO VIA (B)(6). FOR THE SECOND TIME, PART OF THE BRUSH FELL OFF IN MY MOUTH. I WAS ABLE TO RECOGNIZE WHAT HAPPENED AND GET THE PART OUT OF MY MOUTH. BUT I SHOULD HAVE TO THINK WHAT COULD HAPPEN IF THIS OCCURRED TO A CHILD OR ELDERLY PERSON WHO DOESN'T KNOW WHAT BROKE IN THEIR MOUTH BEFORE THEY SWALLOWED IT. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4). JAYRAY INDUSTRIES, INC. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545089 | REPLACEMENT BRUSH HEADS | TOOTHBRUSH, POWERED | JEQ | B. BRAUN / PROCTER & GAMBLE CO. | SB-417A | BOOEY3M44 | |
| 545090 | REPLACEMENT BRUSH HEADS | TOOTHBRUSH, POWERED | JEQ | B. BRAUN / PROCTER & GAMBLE CO. | SB-417A | BOOEY3M44 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |