ORALBPWRORALCARERFLSSENSIULTRATHINEB60
Received Sep 18, 2024
Report 3000302531-2024-00434 · MDR key 20245058
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
14 YR · Female
- Pain
- Unspecified Tissue Injury
- Pain
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
ON 05-NOV-2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.
Description of Event or Problem
CHEEK CAUGHT ON ONE OF YOUR ORAL-B HEADS [MOUTH INJURY]. PAIN - INSIDE CHEEK [ORAL PAIN]. IT TOOK US SOME TIME TO DISLODGE HER CHEEK - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: PARENT REPORTED VIA PHONE THAT THEIR DAUGHTER'S CHEEK GOT CAUGHT ON THE ORAL-B TOOTHBRUSH HEAD WHILE SHE WAS BRUSHING HER TEETH AND HAD TO BE DISLODGED FROM HER CHEEK. NO SERIOUS INJURY WAS REPORTED. ON 02-SEP-2024 VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE PATIENT WAS 14 YEARS OLD AND HAD PAIN INSIDE HER CHEEK. NO MEDICAL PROFESSIONAL WAS CONTACTED. NO SERIOUS INJURY WAS REPORTED.
Description of Event or Problem
CHEEK CAUGHT ON ONE OF YOUR ORAL-B HEADS [MOUTH INJURY]. PAIN - INSIDE CHEEK [ORAL PAIN]. IT TOOK US SOME TIME TO DISLODGE HER CHEEK - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: PARENT REPORTED VIA PHONE THAT THEIR DAUGHTER'S CHEEK GOT CAUGHT ON THE ORAL-B TOOTHBRUSH HEAD WHILE SHE WAS BRUSHING HER TEETH AND HAD TO BE DISLODGED FROM HER CHEEK. NO SERIOUS INJURY WAS REPORTED. ON 02-SEP-2024 VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE PATIENT WAS 14 YEARS OLD AND HAD PAIN INSIDE HER CHEEK. NO MEDICAL PROFESSIONAL WAS CONTACTED. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.