MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for FLOQSWABS manufactured by Copan Diagnostics.
[38084658]
We used the floqswabs (copan flocked swabs) to perform a nasopharyngeal swab. The swab broke at the molded break point while the swab was being performed, hence leaving the tip in the nasopharynx.. Diagnosis or reason for use: research study to determine pneumococcal colonization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060085 |
| MDR Report Key | 5427718 |
| Date Received | 2016-02-05 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-02-04 |
| Date Added to Maude | 2016-02-10 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLOQSWABS |
| Generic Name | COPAN FLOCKED SWABS |
| Product Code | KCJ |
| Date Received | 2016-02-05 |
| Lot Number | 503CS01 |
| Device Expiration Date | 2017-10-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN DIAGNOSTICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-05 |