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 04/15/2019

Event Type  malfunction  

Event Description

Report received of a malfunction resulting in the foam of the oral swab breaking off easily into small and large pieces.Report was received from a review left on (b)(6) on (b)(6) 2019.We were unable to follow up with the reporter for additional information due to no contact information being available.

Manufacturer Narrative

A root cause of the incident could not be identified.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Product history records could not be reviewed as a valid lot code was not provided and could not be obtained.With the currently available information, it cannot be determined or verified if there was or was not an issue with the device.If additional information is received, this complaint will be reopened and updated.Contact information was not able to be obtained from the reporter, sage products llc's phone number, zip code and state was included for the contact information.

• 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
• 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: 12755551
• MDR Text Key: 281746171
• Report Number: 0001419181-2021-00018
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2021

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: Other
• Device Catalogue Number: 6071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/06/2021
• 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: Initial
• Patient Sequence Number: 1