MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC PLS UNTR-20PK 1000; ORAL SWAB

Catalog Number 6071

Device Problem Material Separation (1562)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of returned samples ongoing.

Event Description

Report received of an oral swab disengagement.The reporter stated that the user was self-administering oral care using the oral swab when a piece of the swab disengaged inside the user¿s mouth.Reporter stated the user has been using oral swabs for routine oral care by compressing the swab head between his teeth, due to the user being unable to open his mouth wide enough to fit a standard toothbrush.Reporter stated the user was able to retrieve the disengaged portion of the swab successfully with no adverse consequences.Lot information was provided and product from the same lot is being returned for evaluation.Although requested, no additional information was available.

Event Description

Report received of an oral swab disengagement.The reporter stated that the user was self-administering oral care using the oral swab when a piece of the swab disengaged inside the user¿s mouth.Reporter stated the user has been using oral swabs for routine oral care by compressing the swab head between his teeth, due to the user being unable to open his mouth wide enough to fit a standard toothbrush.Reporter stated the user was able to retrieve the disengaged portion of the swab successfully with no adverse consequences.Lot information was provided and product from the same lot is being returned for evaluation.Although requested, no additional information was available.

Manufacturer Narrative

Reporter returned 46 packages of product from the same lot as the involved device.After evaluation of all the returned oral swabs, it was noted that one of the oral swabs from an up opened pack had the top of the foam separating from the rest of the foam head.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 instructs the user to ¿ensure foam is intact after use.If not, remove any particles from oral cavity.¿ the root cause of the reported complaint could not be determined.

• Brand Name: TOC PLS UNTR-20PK 1000
• Type of Device: ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 12096773
• MDR Text Key: 264502146
• Report Number: 0001419181-2021-00010
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6071
• Device Lot Number: 81428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Event Location: Home
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1