MAUDE Adverse Event Report: MIRACLEAN TECHNOLOGY CO. LTD DISPOSABLE SAMPLING SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number P/N: 93050L

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Tachycardia (2095); Dizziness (2194)

Event Date 03/11/2022

Event Type  Injury  

Event Description

I self swabbed in front of a nurse, just inside my nasal passages for the covid 19 rapid test (i cannot put the swab up inside my nasal cavity due to a history of severe nose bleeds) i used a nasal swab that was given to me unopened and made by miraclean technology co.Ltd.At my work place.The swab felt wet when i inserted it and i immediately felt stinging inside my nose, approximately, 15 minutes later my heart started racing and i felt tightness in my throat.I later felt slightly dizzy.These symptoms lasted for approximately 2 hours before subsiding.I used this brand of swab in (b)(6) 2022 and also experienced stinging inside my nose at that time, however; i did not experience the other symptoms i experienced this time.I have used puritan swabs and did not experience any symptoms, their swabs are dry and so far have not caused me any reaction.Details about the swab that caused my reaction listed here below: manufacturer: miraclean technology co.Ltd, production (b)(4) p/n: 93050l lot:2021030033 mfg date 2021/03/10 exp date 2023/03/09 g.W 1.9g/pc disposable sampling swab single use product sterilized using ethylene oxide use with caution if allergic to foam and pom material.I think these swabs need to be checked for safety.It is my understanding that they should not be wet or cause stinging, nor any other reaction like what i experienced.Fda safety report id #:(b)(4).

• Brand Name: DISPOSABLE SAMPLING SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): MIRACLEAN TECHNOLOGY CO. LTD
• MDR Report Key: 13887283
• MDR Text Key: 288099354
• Report Number: MW5108484
• Device Sequence Number: 2
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/21/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P/N: 93050L
• Patient Sequence Number: 1
• Treatment: CALCIUM; MULTI-VITAMIN; VITAMIN D3; ZINC
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White