MAUDE Adverse Event Report: SAGE PRODUCTS LLC SAGE SELF ORAL CARE 2-PK 24; SUCTION ORAL TOOTHBRUSH

Catalog Number	6302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ongoing.Discarded by facility.
Event or Problem Description
Report received of a malfunction resulting in a toothbrush bristle disengagement.On (b)(6) 2021, an independent patient used the sage self oral care toothbrush to perform oral hygiene.The reporter stated during use of the product a ¿couple¿ bristles came off in the patient¿s mouth.Reporter stated the patient was able to successfully remove all disengaged bristles and no injury occurred.The device was discarded and no pictures were provided.Lot information was provided.Although requested, no additional information was available.
Additional Manufacturer Narrative
Reporter did not provide involved device or photographs of the device, therefore a visual inspection could not be completed.A product history review was completed with all checks showing a passing result.The third party supplier of the involved device was contacted for additional investigation.Their investigation showed that the design did not properly secure the brush head, allowing excessive variation in the brush head position.This could lead to missing tufts or possibly low nylon counts that may lead to loose bristles.This issue has been corrected.The reported complaint is a confirmed manufacturing issue.
Event or Problem Description
Report received of a malfunction resulting in a toothbrush bristle disengagement.On (b)(6) 2021, an independent patient used the sage self oral care toothbrush to perform oral hygiene.The reporter stated during use of the product a ¿couple¿ bristles came off in the patient¿s mouth.Reporter stated the patient was able to successfully remove all disengaged bristles and no injury occurred.The device was discarded and no pictures were provided.Lot information was provided.Although requested, no additional information was available.

• Brand Name: SAGE SELF ORAL CARE 2-PK 24
• Common Device Name: SUCTION ORAL TOOTHBRUSH
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 11467736
• Report Number: 0001419181-2021-00005
• Device Sequence Number: 3776822
• Product Code: JOL
• UDI-Device Identifier: 50618029831199
• UDI-Public: 50618029831199
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 6302
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1