MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for FLOQSWAB manufactured by Copan Diagnostics, Inc..
[98212428]
Patient Sequence No: 1, Text Type: N, H10
[98212429]
While swabbing the patient's right nostril with a flu swab using appropriate technique, upon removing the swab from the nostril, it was noticed that the end of the swab broke off in the patient's nose and remained in the nostril. Patient was instructed to blow out the nose in an attempt to remove the swab. Upon examination, no foreign body was noted or able to be retrieved. Patient was sent to an ent and the swab was retrieved by the ent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7218297 |
| MDR Report Key | 7218297 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-12-28 |
| Report Date | 2018-01-19 |
| Date Reported to FDA | 2018-01-19 |
| Date Reported to Mfgr | 2018-01-19 |
| Date Added to Maude | 2018-01-25 |
| 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 |
| 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 | FLOQSWAB |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | KXG |
| Date Received | 2018-01-25 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-01-25 |