MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ACCEAVEA STREP KIT; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Lot Number STA2042019;000061857

Device Problems Material Separation (1562); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Choking (2464)

Event Date 04/19/2023

Event Type  Injury  

Event Description

Reporter called with complaint of defective cotton swabs in the acceavea strep kits.The tips of the swabs have been separating and /or breaking off of the main part of the applicator wand.Yesterday, while swabbing a 5-year old's throat, the tip of the swab detached from the applicator and went down the child's throat.The child choked and then expectorated the swab (cotton section).The child is okay but this is being reported because this can be an issue with future patients/customers.

• Brand Name: ACCEAVEA STREP KIT
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): ALERE SAN DIEGO, INC.
• MDR Report Key: 16789242
• MDR Text Key: 313811727
• Report Number: MW5116883
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: STA2042019;000061857
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Patient Sequence Number: 1
• Patient Age: 5 YR