MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-25 for FLOQSWABS 518CS01 manufactured by Copan Flock Technologies, S.r.l.
[5575178]
A report was sent by the initial reporter to (b)(4). Copan diagnostics, as copan flock technologies us agent, received the report from fda on 03/02/2015 as first and sole notification of the event. The description of the event in the report submitted by the user was as follows: "while obtaining a viral flue swab specimen, the snap off portion of the swab was retained in the left nare (nostril) of the patient. The physician (md) was informed. Nasal and nasopharyngeal suctioning was performed without successful object removal. The md used a fiberoptic scope to examine inside the nares without results. Device usage problem: device failed (e. G. Broken, couldn't get it to work or stopped working)" ref mfr #3002444944-2015-00003.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2436875-2015-00001 |
| MDR Report Key | 4641518 |
| Date Received | 2015-03-25 |
| Date of Report | 2015-03-02 |
| Date of Event | 2014-12-09 |
| Date Facility Aware | 2015-03-02 |
| Report Date | 2015-03-02 |
| Date Reported to FDA | 2015-03-25 |
| Date Reported to Mfgr | 2015-03-02 |
| Date Added to Maude | 2015-03-31 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Manufacturer Street | 2175 SAMPSON AVE., SUITE 124 |
| Manufacturer City | CORONA CA 91719 |
| Manufacturer Country | US |
| Manufacturer Postal | 91719 |
| Manufacturer G1 | COPAN DIAGNOSTICS, INC. |
| Manufacturer Street | 2175 SAMPSON AVE., SUITE 124 |
| Manufacturer City | CORONA CA 91719 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91719 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOQSWABS |
| Generic Name | APPLICATOR, ABSORBENT TIPS, STERILE |
| Product Code | KXG |
| Date Received | 2015-03-25 |
| Model Number | 518CS01 |
| Catalog Number | 518CS01 |
| Lot Number | AE3500 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES, S.R.L |
| Manufacturer Address | VIA F. PEROTTI 16-18 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-25 |