FDA Adverse Event
Malfunction
Summary report: N
OXYGEN W/FOAM 10/040CM/71DG0O +
MDR report key: 5291115
·
Received December 11, 2015
Report
- Report Number
- 3005778470-2015-40057
- Event Type
- Malfunction
- Date Received
- December 11, 2015
- Report Date
- November 6, 2015
- Manufacturer
- UNOMEDICAL S.R.O.
- Product Code
- BZB
- PMA / PMN Number
- K896731
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4) AND PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem · 1
COMPLAINANT REPORTS "KINKS IN THE TUBE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818552 | OXYGEN W/FOAM 10/040CM/71DG0O + | CATHETER, NASAL, OXYGEN | BZB | UNOMEDICAL S.R.O. | 19055339 | 463296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |