MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-23 for ORALBPWRPWRORALCARERFLSPRECISIONCLEAN manufactured by Braun Gmbh Werk Marktheidenfeld.
[71050031]
Return of product has been requested. Product and lot number not provided by the reporter, therefore unable to proceed with product investigation at this time. Full evaluation will occur upon receipt of the returned product.
Patient Sequence No: 1, Text Type: N, H10
[71050032]
Brush at back of throat [foreign body]; brushes broke off and detached in mouth while brushing [device breakage]. Case description: a female consumer of unspecified age reported via e-mail on 24-feb-2017 that while brushing with an oral-b rechargeable toothbrush, version unknown on an unspecified date, the oral-b brushheads, version unknown broke off and detached in her mouth. The brush head had been in use about three weeks before breaking. She reported she was brushing by hand at the moment. She had used a braun electric toothbrush with oral-b brush heads for years and had never experienced any problems. No symptoms were reported. On 01-mar-2017 consumer follow-up via e-mail: the consumer submitted pictures revealing the product was oral-b power oral care refills precision clean. The consumer reported she scratched the gray oral-b logo with a coin on the side, but nothing happened. She still had 2 unused brush heads from the pack of 4. She was no longer using the product. No symptoms were reported. On 06-mar-2017 consumer follow-up via e-mail: the consumer reported that fortunately it ended well when the brush head ended up at the back of her throat. The case outcome was recovered.
Patient Sequence No: 1, Text Type: D, B5
[78167506]
On (b)(6) 2017 product investigation results: reporter returned 7 toothbrush heads on (b)(6) 2017. Toothbrush heads confirmed to be counterfeit.
Patient Sequence No: 1, Text Type: N, H10
[78167507]
Brush at back of throat [foreign body], brushes broke off and detached in mouth while brushing [device breakage], product counterfeit [product counterfeit]. Case description: a female consumer of unspecified age reported via e-mail on (b)(6) 2017 that while brushing with an oral-b rechargeable toothbrush, version unknown on an unspecified date, the oral-b brushheads, version unknown broke off and detached in her mouth. The brush head had been in use about three weeks before breaking. She reported she was brushing by hand at the moment. She had used a braun electric toothbrush with oral-b brush heads for years and had never experienced any problems. No symptoms were reported. On (b)(6) 2017 consumer follow-up via e-mail: the consumer submitted pictures revealing the product was oral-b power oral care refills precision clean. The consumer reported she scratched the gray oral-b logo with a coin on the side, but nothing happened. She still had 2 unused brush heads from the pack of 4. She was no longer using the product. No symptoms were reported. On (b)(6) 2017 consumer follow-up via e-mail: the consumer reported that fortunately it ended well when the brush head ended up at the back of her throat. The case outcome was recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000302531-2017-00120 |
| MDR Report Key | 6428370 |
| Date Received | 2017-03-23 |
| Date of Report | 2017-02-24 |
| Date Mfgr Received | 2017-05-18 |
| Date Added to Maude | 2017-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORALBPWRPWRORALCARERFLSPRECISIONCLEAN |
| Generic Name | TOOTHBRUSH, POWERED |
| Product Code | JRQ |
| Date Received | 2017-03-23 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAUN GMBH WERK MARKTHEIDENFELD |
| Manufacturer Address | 40 BAUMHOFSTRASSE MARKTHEIDENFELD, D-97828 GM D-97828 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-23 |