ORALBPWRORALCARERFLSPRECISIONCLEANEB20
Received Sep 23, 2025
Report 3000302531-2025-00425 · MDR key 23120976
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
49 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
13-NOV-2025, 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
HEAD COMES OFF DURING BRUSHING- ORAL B POWER CARE [DEVICE BREAKAGE] . HEAD DOESN¿T SEEM TO FIT PROPERLY- ORAL B POWER CARE [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER EMAIL STATED THAT DURING BRUSHING HEAD COMES OFF AND HEAD DOESN¿T SEEM TO FIT PROPERLY. NO INJURY WAS REPORTED. 13-NOV-2025, PRODUCT INVESTIGATION RESULT: CONCLUSION CODE: OTHER, NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION. NO INJURY WAS REPORTED.
Description of Event or Problem
HEAD COMES OFF DURING BRUSHING- ORAL B POWER CARE [DEVICE BREAKAGE]. HEAD DOESN¿T SEEM TO FIT PROPERLY- ORAL B POWER CARE [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER EMAIL STATED THAT DURING BRUSHING HEAD COMES OFF AND HEAD DOESN¿T SEEM TO FIT PROPERLY. NO INJURY WAS REPORTED. 13-NOV-2025, PRODUCT INVESTIGATION RESULT: CONCLUSION CODE: OTHER, NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION. NO INJURY WAS REPORTED. FOLLOW-UP (09-DEC-2025): PRODUCT BATCH / LOT CODE ADDED. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
13-NOV-2025, PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.
Additional Manufacturer Narrative
PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
HEAD COMES OFF DURING BRUSHING- ORAL B POWER CARE [DEVICE BREAKAGE]. HEAD DOESN¿T SEEM TO FIT PROPERLY- ORAL B POWER CARE [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER EMAIL STATED THAT DURING BRUSHING HEAD COMES OFF AND HEAD DOESN¿T SEEM TO FIT PROPERLY. NO INJURY WAS REPORTED.