MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for TRANSYSTEM STERILE TRANSPORT SWAB 900-0370 manufactured by Copan Diagnostics, Inc..
[182983513]
Sterile swabstick noted to be defective with one swab in package. This was in 2 different packages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9818401 |
| MDR Report Key | 9818401 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-02 |
| Report Date | 2020-02-14 |
| Date Reported to FDA | 2020-02-14 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSYSTEM STERILE TRANSPORT SWAB |
| Generic Name | CULTURE MEDIA, NON-PROPAGATING TRANSPORT |
| Product Code | JSM |
| Date Received | 2020-03-11 |
| Model Number | 900-0370 |
| Catalog Number | 900-0370 |
| Lot Number | 191199200 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN DIAGNOSTICS, INC. |
| Manufacturer Address | 26055 JEFFERSON AVENUE MURRIETA CA 92562 US 92562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |