MAUDE Adverse Event Report: FOAMTEC INTERNATIONAL CO., LTD. FOAMTEC NASAL SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 0625202140

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/11/2020

Event Type  Injury  

Event Description

Swab tip broke off in nares during lab testing; retrieved.Fda safety report id # (b)(4).

• Brand Name: FOAMTEC NASAL SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): FOAMTEC INTERNATIONAL CO., LTD.
• MDR Report Key: 10307464
• MDR Text Key: 200195753
• Report Number: MW5095643
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2020

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: No Information
• Device Expiration Date: 12/01/2020
• Device Lot Number: 0625202140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR