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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS PCR MEDIA DUAL SWAB SAMPLE KIT; SPECIMEN COLLECTION KIT
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ROCHE MOLECULAR SYSTEMS, INC. COBAS PCR MEDIA DUAL SWAB SAMPLE KIT; SPECIMEN COLLECTION KIT Back to Search Results
Catalog Number 07958021190
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 05/15/2020
Event Type  Injury  
Manufacturer Narrative
Through the reported case, it was noted that the cobas pcr media dual swab was not broken prior to use.No kit lot information was provided although requested.(b)(4).
 
Event Description
A customer in (b)(6) reported the shaft of the cobas pcr media dual swab sample kit broke in a patient's mouth during sample collection as the patient bit down unexpectedly.As a consequence, the patient's oral cavity was inspected and a bronchoscopy and x-ray was performed.It was indicated that the broken shaft could not be found.There was no indication of any serious deterioration in the patient's state of health.
 
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Brand Name
COBAS PCR MEDIA DUAL SWAB SAMPLE KIT
Type of Device
SPECIMEN COLLECTION KIT
Manufacturer (Section D)
ROCHE MOLECULAR SYSTEMS, INC.
1080 us highway 202 south
branchburg NJ 08876
Manufacturer Contact
stacie-ann creighton
1080 us hwy 202 s
na
branchburg, NJ 08876
9082537112
MDR Report Key10122723
MDR Text Key194116596
Report Number2243471-2020-00011
Device Sequence Number1
Product Code MKZ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K163184
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/05/2020
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 Operator Health Professional
Device Catalogue Number07958021190
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2020
Initial Date FDA Received06/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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