ORALBRCHGTOOTHBRUSHHANDLE3766
Received May 7, 2025
Report 3000302531-2025-00175 · MDR key 21975363
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
59 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
29-APR-2025- PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
HEAD COMES OFF - ORAL-B POWER REFILL [DEVICE BREAKAGE]. CASE NARRATIVE: CUSTOMER E-MAIL STATED THAT WHILE BRUSHING, HEAD COMES OFF (ORAL B HEADS FOR MY ELECTRIC TOOTHBRUSH). NO INJURY WAS REPORTED. 07-MAY-2025, DEVICE COMPONENT INFORMATION ADDED TO DATA RECEIVED ON 30-APR-2025.
Additional Manufacturer Narrative
15-JUL-2025: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.
Description of Event or Problem
HEAD COMES OFF - ORAL-B POWER REFILL [DEVICE BREAKAGE]. CASE NARRATIVE: CUSTOMER E-MAIL STATED THAT WHILE BRUSHING, HEAD COMES OFF (ORAL B HEADS FOR MY ELECTRIC TOOTHBRUSH). NO INJURY WAS REPORTED. 07-MAY-2025, DEVICE COMPONENT INFORMATION ADDED TO DATA RECEIVED ON 30-APR-2025. 21-MAY-2025 (PRODUCT INVESTIGATIONS RESULT): PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS. NO INJURY WAS REPORTED. 10-JUN-2025 (GERMAN NOTES - ORAL-B TOOTHBRUSH HANDLE ADDITIONAL MANUFACTURER NARRATIVE ADDED TO DATA. FOLLOW UP : GERMAN NOTES- CONCLUSION - OTHER NO MANUFACTURING CAUSE AND NO DESIGN ISSUE WAS IDENTIFIED BASED ON INVESTIGATION RESULTS. FOLLOW UP : PRODUCT INVESTIGATION RESULT: EVALUATION / INVESTIGATION CODE INFORMATION UPDATED TO DATA. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
ON 21-MAY-2025 - 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 - ORAL-B POWER REFILL [DEVICE BREAKAGE]. CASE NARRATIVE: CUSTOMER E-MAIL STATED THAT WHILE BRUSHING, HEAD COMES OFF (ORAL B HEADS FOR MY ELECTRIC TOOTHBRUSH). NO INJURY WAS REPORTED. ON 07-MAY-2025, DEVICE COMPONENT INFORMATION ADDED TO DATA RECEIVED ON 30-APR-2025. ON (B)(6) 2025 (PRODUCT INVESTIGATIONS RESULT): PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
ON 10-JUN-2025 - PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
HEAD COMES OFF - ORAL-B POWER REFILL [DEVICE BREAKAGE]. CASE NARRATIVE: CUSTOMER E-MAIL STATED THAT WHILE BRUSHING, HEAD COMES OFF (ORAL B HEADS FOR MY ELECTRIC TOOTHBRUSH). NO INJURY WAS REPORTED. ON 07-MAY-2025, DEVICE COMPONENT INFORMATION ADDED TO DATA RECEIVED ON 30-APR-2025. ON 21-MAY-2025 (PRODUCT INVESTIGATIONS RESULT): PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED; THE PRODUCT IS ACCORDING TO SPECIFICATIONS. NO INJURY WAS REPORTED. ON 10-JUN-2025 (GERMAN NOTES - ORAL-B TOOTHBRUSH HANDLE): ADDITIONAL MANUFACTURER NARRATIVE ADDED TO DATA RECEIVED ON 10-JUN-2025. ON 24-JUN-2025 (GERMAN NOTES- CONCLUSION - OTHER): NO MANUFACTURING CAUSE AND NO DESIGN ISSUE WAS IDENTIFIED BASED ON INVESTIGATION RESULTS RECEIVED ON 23-JUN-2025.