MAUDE Adverse Event Report: HOLOGIC INCORPORATED APTIMA MULTITEST SPECIMEN COLLECTION KIT; DEVICE, SPECIMEN COLLECTION

Model Number	MULTITEST SWAB COLLECTION KIT,APTIMA,IVD
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The person who call technical support (ts) is from a collection site and was not able to provide detailed information.Ts directed the customer to the product's safety data sheet (sds).Per the sds, transport media contains no substances, which at their given concentration, are considered to be hazardous to health per the safety data sheet, osha hazard classification.Section 4 first aid measures from safety data sheet (sds) transport media/ collection devices (revision date (b)(6) 2021), the treatment for ingestion is: "clean mouth with water and drink afterwards plenty of water.If symptoms persist, call a physician." in addition, physicians would treat the patients based upon their symptoms.Ts tried three attempts to reach customer to follow up on the case to check whether the first aid recommendations were followed.Patient treatment is unknown.The context surrounding the child ingesting the stm is unknown.There have been no similar occurrences of transport media being inadvertently ingested or swallowed in the past 12 months.
Event or Problem Description
On (b)(6) 2022, customer reported to hologic technical support (ts) that a patient's child ingested specimen transport media (stm) from an aptima multitest transport tube.Ts directed the customer to safety data sheet (sds) of the product for first aid guidance.

• Brand Name: APTIMA MULTITEST SPECIMEN COLLECTION KIT
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 14182727
• Report Number: 2024800-2022-00135
• Device Sequence Number: 6011011
• Product Code: LSL
• UDI-Device Identifier: 25420045510187
• UDI-Public: 25420045510187
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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?: No
• Device Model Number: MULTITEST SWAB COLLECTION KIT,APTIMA,IVD
• Device Catalogue Number: ASY-08848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown