MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL TOC SOB-SOS-SWAB-UNTR 100; SUCTION ORAL BRUSH

Catalog Number 6576-X

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

Samples were not available for evaluation.The reporter did provide two lot numbers that were each evaluated.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per the product drawing.A labeling review of the finished good was performed.The packaging label includes the following instructions, "do not allow patient to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or those who cannot comprehend commands.Use caution with children and unresponsive individuals.Failure to follow these safety precautions may damage the device and present a chocking/aspiration hazard.May not function as intended/potential risk of cross-contamination if device is reused." the exact root cause of the reported issue could not be determined, however; is most likely due to the reporter reusing the device although it is possible that the glue used to adhere the foam to the suction toothbrush may had been used passed its expiry.

Event Description

Report received of a suction oral brush user error resulting in foam disengagement.Reporter stated oral care was performed on an elderly female patient at home when the entire piece of foam became disengaged from the suction oral brush inside the patient¿s mouth.Reporter stated the patient was alert and oriented and did not bite down on the suction oral brush stick.The disengaged foam was removed from the patient¿s mouth with a suction probe.Reporter stated the suction oral brush was reused several times and that the patient¿s daughter was educated in regard to the device being single use only.The reporter stated patient did not experience any serious outcomes or delays in treatment.Involved device was discarded.The two lot numbers that were shipped to the patient¿s house were provided, however the reporter was not able to confirm which lot number was associated with the involved device, both reported lot numbers will be evaluated.Although requested, no additional information was available.

• Brand Name: INTL TOC SOB-SOS-SWAB-UNTR 100
• Type of Device: SUCTION ORAL BRUSH
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 14492667
• MDR Text Key: 292593419
• Report Number: 0001419181-2022-00003
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6576-X
• Device Lot Number: 83614; 80859
• Was Device Available for Evaluation?: No
• Event Location: Home
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female