ORALBPWRORALCARERFLSSIMPLYCLEANEB17B
Received Jun 9, 2023
Report 3000302531-2023-00243 · MDR key 17100595
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
66 YR · Male
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
29-AUG-2023 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.
Description of Event or Problem
SCRATCHED FACE WITH THE METAL VIBRATING STEM ON THE HANDLE ASSY [SCRATCH] BRUSH HEAD IS NOT SECURELY ATTACHING ITSELF TO HANDLE ASSY AND IT WILL SEPARATE - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD WAS NOT SECURELY ATTACHING ITSELF TO THEIR ORAL-B TOOTHBRUSH HANDLE ASSY AND WOULD SEPARATE. THEY SCRATCHED THEIR FACE WITH THE METAL VIBRATING STEM ON THE ORAL-B TOOTHBRUSH HANDLE ASSY. NO SERIOUS INJURY WAS REPORTED. 30-MAY-2023 FOLLOW UP VIA DIGITAL SURVERY: THE CONSUMER WAS A 66-YEAR-OLD MALE. HE DID NOT SEEK ADVICE FROM A HEALTHCARE PROVIDER. NO SERIOUS INJURY WAS REPORTED. 01-JUN-2023 CASE UPDATE FROM INFORMATION RECEIVED IN THE FOLLOW UP VIA IMAGES RECEIVED ON 26-MAY-2023: THE CONCOMITANT PRODUCT WAS ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE 3710. NO SERIOUS INJURY WAS REPORTED. 17-AUG-2023 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 03-JUL-2023: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS SIMPLY CLEAN EB17B. THE CONCOMITANT PRODUCT LOT WAS 1RF94651620. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
SCRATCHED FACE WITH THE METAL VIBRATING STEM ON THE HANDLE ASSY [SCRATCH] BRUSH HEAD IS NOT SECURELY ATTACHING ITSELF TO HANDLE ASSY AND IT WILL SEPARATE - ORAL-B [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD WAS NOT SECURELY ATTACHING ITSELF TO THEIR ORAL-B TOOTHBRUSH HANDLE ASSY AND WOULD SEPARATE. THEY SCRATCHED THEIR FACE WITH THE METAL VIBRATING STEM ON THE ORAL-B TOOTHBRUSH HANDLE ASSY. NO SERIOUS INJURY WAS REPORTED. (B)(6)2023 FOLLOW UP VIA DIGITAL SURVEY: THE CONSUMER WAS A 66-YEAR-OLD MALE. HE DID NOT SEEK ADVICE FROM A HEALTHCARE PROVIDER. NO SERIOUS INJURY WAS REPORTED. (B)(6)2023 CASE UPDATE FROM INFORMATION RECEIVED IN THE FOLLOW UP VIA IMAGES RECEIVED ON (B)(6)2023: THE CONCOMITANT PRODUCT WAS ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE 3710. NO SERIOUS INJURY WAS REPORTED.