ORALBPWRORALCARERFLSCROSSACTNEB50BLACK
Received Dec 8, 2025
Report 3000302531-2025-00548 · MDR key 23740816
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
56 YR · Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN. H3 OTHER TEXT: PENDING INVESTIGATION.
Description of Event or Problem
PINCHES SHARPLY THE INSIDE OF MOUTH [MOUTH INJURY]. BLEEDING - MOUTH [MOUTH HAEMORRHAGE]. PINCHED ON MY LIPS [LIP INJURY]. BLEEDING - LIPS [LIP HAEMORRHAGE]. [ORAL-B] TOOTHBRUSH HEAD SPLIT ALONG THE REMOVABLE BRUSH STEM [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA WEB STATED THAT THE TOOTHBRUSH HEAD SPLIT ALONG THE REMOVABLE BRUSH STEM. DUE TO THIS SPLIT IN THE PLASTIC, IT PINCHED ON HIS LIPS AND MOUTH CAUSING MINOR BLEEDING. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP 15-JAN-2026: SUSPECT PRODUCT WAS UPDATED. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
05-FEB-2026 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.
Description of Event or Problem
PINCHES SHARPLY THE INSIDE OF MOUTH [MOUTH INJURY], BLEEDING - MOUTH [MOUTH HAEMORRHAGE], PINCHED ON MY LIPS [LIP INJURY], BLEEDING - LIPS [LIP HAEMORRHAGE], [ORAL-B] TOOTHBRUSH HEAD SPLIT ALONG THE REMOVABLE BRUSH STEM [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA WEB STATED THAT THE TOOTHBRUSH HEAD SPLIT ALONG THE REMOVABLE BRUSH STEM. DUE TO THIS SPLIT IN THE PLASTIC, IT PINCHED ON HIS LIPS AND MOUTH CAUSING MINOR BLEEDING. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP 15-JAN-2026: SUSPECT PRODUCT WAS UPDATED. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP 05-FEB-2026: PRODUCT INVESTIGATION RESULTS: 'NO MANUFACTURING CAUSE' AND 'NO DESIGN ISSUE' IDENTIFIED BASED ON INVESTIGATION. 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
PINCHES SHARPLY THE INSIDE OF MOUTH [MOUTH INJURY]. BLEEDING - MOUTH [MOUTH HAEMORRHAGE]. PINCHED ON MY LIPS [LIP INJURY]. BLEEDING - LIPS [LIP HAEMORRHAGE]. [ORAL-B] TOOTHBRUSH HEAD SPLIT ALONG THE REMOVABLE BRUSH STEM [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA WEB STATED THAT THE TOOTHBRUSH HEAD SPLIT ALONG THE REMOVABLE BRUSH STEM. DUE TO THIS SPLIT IN THE PLASTIC, IT PINCHED ON HIS LIPS AND MOUTH CAUSING MINOR BLEEDING. NO SERIOUS INJURY WAS REPORTED.