MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-05-04 for COBAS? PCR MEDIA DUAL SWAB SAMPLE KIT 07958021190 manufactured by Roche Molecular Systems,inc..
[107337865]
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 patient did not seek any specific medical attention. The customer indicated that they followed up with the patient and the issue is now closed; however, no further details were provided. The udi for the cobas pcr media dual swab sample kit is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107337866]
A (b)(6) customer stated that one of their patients was issued a self collection swab and put cobas? Pcr media in her mouth. The patient felt numbness on tongue and lips. No medical treatment was provided; the patient was instructed to drink a lot of water. There is no indication of harm or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00005 |
| MDR Report Key | 7486444 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS? PCR MEDIA DUAL SWAB SAMPLE KIT |
| Generic Name | SPECIMEN COLLECTION KIT |
| Product Code | MKZ |
| Date Received | 2018-05-04 |
| Model Number | NA |
| Catalog Number | 07958021190 |
| Lot Number | NI |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS,INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-04 |