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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE; IN-VITRO DIAGNOSTIC
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HOLOGIC, INC. KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE; IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 301041-01
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code Injury (2348)
Date of Event 07/30/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Customer, (b)(6), reported an incident where a child ingested an unknown volume of aptima transport media, prior to collection of sample.The swab collection tube contains soln., transport media (pn: 101768).The child was given plenty of water to drink as treatment.Per the safety data sheet for transport media/collection devices (rev.Date 06/25/2018), the first aid measure for ingestion is to "clean mouth with water and drink afterwards plenty of water.If symptoms persist, call a physician".In addition, the product contains no substances, which at their given concentration, are considered to be hazardous to health.Customer has not called back for any other issues.
 
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Brand Name
KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE
Common Device Name
IN-VITRO DIAGNOSTIC
Manufacturer (Section D)
HOLOGIC, INC.
10210 genetic center dr.
san diego CA 92121
MDR Report Key7806222
Report Number2024800-2018-00007
Device Sequence Number1469040
Product Code LIO
UDI-Device Identifier25420045506272
UDI-Public25420045506272
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K111409
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/22/2018
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
Operator of Device No Information
Device Catalogue Number301041-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/30/2018
Initial Report FDA Received Date08/22/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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