MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-05-29 for ICU/O2 & AEROSOL/CATHETER 19035182 manufactured by Unomedical S.r.o..
[4568917]
It is reported while patient was undergoing diathermy during use of the product, a spark was generated which became a flame. The oxygen was turned on at a rate of 2 liters per min. The flame progressed through delivery device to patient resulting in superficial nostril burn. The patient recovered completely without any treatment and was discharged normally. It is reported that the incident affected two (2) elderly patients.
Patient Sequence No: 1, Text Type: D, B5
[12092408]
Based on the available information, this event is deemed to be a serious injury. It is reported that both were outpatient procedures, but in different centers (they have two centers) by different surgeons. Both were excisions of in situ skin cancer near the nostril. In the other nostril, they had the catheter directing the oxygen flow. It is their routine procedure. When using the electrocauther, there was a spark and a flame which had never happened before. An investigation performed on (b)(4) 2011 based on evaluation of two (2) unused samples (lot no(s) 399286 and 401737) in closed peel pack were received and tested. The samples provided were tested, including visual test, measurements against the drawing and we determined that it met our specified requirements. In conclusion, the investigation of this matter has been done previously and the results are available in a documented corrective action preventative action (capa) event. Note: this is the first instance where the patient had a slight burn on the nostril. This case is related to patient dentifer #: (b)(6) reported under manufacturer's report #: 3005778470-2014-00031. No additional patient/event details have been provided to date. Should additional information become available, a follow-up report will be submitted. Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from (b)(4) 2011 - (b)(4) 2013. Reported to the fda on may 28, 2014. Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00030 |
| MDR Report Key | 3879462 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-05-29 |
| Date of Report | 2011-08-26 |
| Date of Event | 2011-08-24 |
| Date Mfgr Received | 2011-08-26 |
| Date Added to Maude | 2014-06-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, ASSOCIATE DIR. |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICU/O2 & AEROSOL/CATHETER |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2014-05-29 |
| Returned To Mfg | 2011-09-22 |
| Model Number | 19035182 |
| Catalog Number | 19035182 |
| Lot Number | 401737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-29 |