ORALBPWRORALCARERFLSCROSSACTNEB50
Received Dec 5, 2025
Report 3000302531-2025-00543 · MDR key 23725243
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
29 YR · Male
- Dyspnea
- Pain
- Ulcer
- Choking
- Upper Respiratory Tract Injury
- Dyspnea
- Pain
- Ulcer
- Choking
- Upper Respiratory Tract Injury
Narrative
Additional Manufacturer Narrative
27-FEB-2026 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.
Description of Event or Problem
[ORAL-B TOOTHBRUSH HEAD] BECAME LODGED IN THROAT [FOREIGN BODY IN THROAT] ,CHOKING INCIDENT [CHOKING] , (PAINFUL) ULCER- MOUTH [MOUTH ULCERATION] , STRUGGLED TO BREATHE PROPERLY [DYSPNOEA] , PAINFUL (ULCER)- MOUTH [ORAL PAIN] , [ORAL-B TOOTHBRUSH HEAD] DETACHED DURING USE [DEVICE BREAKAGE] , PRODUCT COUNTERFEIT- ORAL-B [PRODUCT COUNTERFEIT] . CASE NARRATIVE: CONSUMER VIA WEB STATED THAT ORAL-B TOOTHBRUSH HEAD DETACHED DURING USE. NO SERIOUS INJURY WAS REPORTED. 11-DEC-2025 (FOLLOW UP): LOT CODE WAS ADDED FOR CONCOMITANT (HANDLE). NO SERIOUS INJURY WAS REPORTED. 27-FEB-2026 PRODUCT INVESTIGATION RESULTS: THE PRODUCT INVOLVED WAS CONFIRMED TO BE A COUNTERFEIT, SO THE PRODUCT PROBLEM WILL BE REMOVED FROM THE ORAL-B TOOTHBRUSH HEAD REFILL. 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
[ORAL-B TOOTHBRUSH HEAD] BECAME LODGED IN THROAT [FOREIGN BODY IN THROAT] CHOKING INCIDENT [CHOKING] (PAINFUL) ULCER- MOUTH [MOUTH ULCERATION] STRUGGLED TO BREATHE PROPERLY [DYSPNOEA] PAINFUL (ULCER)- MOUTH [ORAL PAIN] [ORAL-B TOOTHBRUSH HEAD] DETACHED DURING USE [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER VIA WEB STATED THAT ORAL-B TOOTHBRUSH HEAD DETACHED DURING USE. 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
[ORAL-B TOOTHBRUSH HEAD] BECAME LODGED IN THROAT [FOREIGN BODY IN THROAT] CHOKING INCIDENT [CHOKING] (PAINFUL) ULCER- MOUTH [MOUTH ULCERATION] STRUGGLED TO BREATHE PROPERLY [DYSPNOEA] PAINFUL (ULCER)- MOUTH [ORAL PAIN] [ORAL-B TOOTHBRUSH HEAD] DETACHED DURING USE [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER VIA WEB STATED THAT ORAL-B TOOTHBRUSH HEAD DETACHED DURING USE. NO SERIOUS INJURY WAS REPORTED. (B)(6) 2025 (FOLLOW UP): LOT CODE WAS ADDED FOR CONCOMITANT (HANDLE). NO SERIOUS INJURY WAS REPORTED.