MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-04 for FLOCKED SWAB APPLICATOR MDD CE0344 H282- REV 1107.0 manufactured by Copan Diagnostics Incs..
[1516385]
Applicator opened and inserted into the right nare and rotated as procedure. Following the 15 seconds in the nare, the application was removed noting that the swab was not on the tip of the applicator. Applicator had broken off not at the perforated area but closer to the swab leaving the swab in the nare unobtainable, patient transferred to ed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013869 |
| MDR Report Key | 1556591 |
| Date Received | 2009-12-04 |
| Date of Report | 2009-12-04 |
| Date of Event | 2009-11-02 |
| Date Added to Maude | 2009-12-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOCKED SWAB APPLICATOR |
| Generic Name | NASOPHARYNX SWAB |
| Product Code | KCJ |
| Date Received | 2009-12-04 |
| Model Number | MDD CE0344 |
| Catalog Number | H282- REV 1107.0 |
| Lot Number | 519CS01M |
| ID Number | 004E05 L. JLS700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN DIAGNOSTICS INCS. |
| Manufacturer Address | 26055 JEFFERSON AVENUE MURRIETA CA 92562 US 92562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-04 |