MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-04-06 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies Srl.
[41948601]
A report was sent by the initial reporter (b)(6) to fda (mw5060085). (b)(4), as copan flock technologies us agent, became aware of the event on (b)(6) 2016 through fda letter. On the same day (b)(4) informed copan flock technologies. The medwatch from fda was received in the mailbox by (b)(4) as first and sole notification of the event. The description of the event in the report submitted by the user was as follows: "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. " on (b)(6) 2016 an email was sent to dr. (b)(6), physician at (b)(6), asking to fill in a questionnaire in order to acquire more information about the event. On (b)(6) 2016 dr. (b)(6) replied with the filled in questionnaire which contained the following information: the event occurred on (b)(6) 2016 at (b)(6) hospital: a female patient over 65 years was swabbed in nasopharynx. The purpose of sampling was to investigate the presence of pneumococcus pathogen. The patient was collaborative and not sedated during the collection. The swab broke in correspondence to the diameter change, so in a different point than the one indicated in mw5060085, leaving the tip in the nasopharynx of the patient. We also received a picture of the broken swab. Dr. (b)(6) provided also more information by email : "ent did finally come to the ed. They performed a scope and saw no fragment left. The patient has not seen the tip in her stool. The patient has been doing well. My nurse spoke with her about 2 weeks ago. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2016-00002 |
| MDR Report Key | 5549697 |
| Report Source | OTHER |
| Date Received | 2016-04-06 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-02-04 |
| Date Facility Aware | 2016-03-14 |
| Report Date | 2016-04-06 |
| Date Reported to FDA | 2016-04-06 |
| Date Reported to Mfgr | 2016-03-14 |
| Date Mfgr Received | 2016-03-14 |
| Device Manufacturer Date | 2017-10-30 |
| Date Added to Maude | 2016-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. STEFANIA TRIVA |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 9030268721 |
| Manufacturer G1 | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, ITALY 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 25125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOQSWAB |
| Generic Name | APPLICATOR, ABSORBENT TIP, STERILE |
| Product Code | KXG |
| Date Received | 2016-04-06 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | RMJQ00 |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Address | VIA F. PEROTTI 16-18 BRESCIA, BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-06 |