MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS PCR MEDIA DUAL SWAB SAMPLE KIT; SPECIMEN COLLECTION KIT

Catalog Number 07958021190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

As stated in the cobas pcr media dual swab sample kit instructions for use, avoid contact of the cobas pcr media with the skin, eyes or mucous membranes.If contact does occur, immediately wash with large amounts of water.The safety data sheet for the media further states it is harmful if swallowed.Clean mouth with water and drink afterwards plenty of water.Keep respiratory tract clear.No harm or serious injury was alleged, and the child did not seek any specific medical attention.(b)(4).

Event Description

A us customer stated that a (b)(6) year child may have ingested a small amount of cobas dual swab pcr media.Poison control center was contacted, and they advised to treat as an irritant.The child was not seen or treated by a medical professional.The child was in a stable condition with no change to health.No additional details were provided.

• 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 Key: 8939410
• MDR Text Key: 156821861
• Report Number: 2243471-2019-00034
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2019

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: No Information
• Device Catalogue Number: 07958021190
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/28/2019
• 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 Number: 1
• Patient Age: 2 YR