MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-10 for MICRORHEOLOGICS FLOCKED SWAB * 551C manufactured by Copan Italia.
[21385131]
Swab was used to collect a nasopharyngeal specimen. As swab was removed, it was noted that the tip end of the swab remained in pt's nose. Pt described a discomfort of something being initially stuck in nose and later said that she believed it had been swallowed. At no point did pt appear to be in acute distress or discomfort beyond that associated with a blocked nasal passageway. The swab tip could not be seen in the nose or throat; it was not retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006204 |
| MDR Report Key | 1027706 |
| Date Received | 2008-04-10 |
| Date of Report | 2008-03-28 |
| Date of Event | 2008-03-19 |
| Date Added to Maude | 2008-04-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRORHEOLOGICS FLOCKED SWAB |
| Generic Name | SPECIMEN COLLECTION SWAB |
| Product Code | LIO |
| Date Received | 2008-04-10 |
| Model Number | * |
| Catalog Number | 551C |
| Lot Number | E17 1 RTK00 |
| ID Number | * |
| Device Expiration Date | 2009-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 995442 |
| Manufacturer | COPAN ITALIA |
| Manufacturer Address | VIA F. PEROTTI, 10 BRESCIA IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-10 |