MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-12-11 for OXYGEN W/FOAM 10/040CM/71DG0O + 19055339 manufactured by Unomedical S.r.o..
[33328036]
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).
Patient Sequence No: 1, Text Type: N, H10
[33328037]
Complainant reports "kinks in the tube. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2015-40057 |
| MDR Report Key | 5291115 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-06 |
| Date Mfgr Received | 2015-11-06 |
| Date Added to Maude | 2015-12-11 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN W/FOAM 10/040CM/71DG0O + |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2015-12-11 |
| Returned To Mfg | 2013-03-11 |
| Model Number | 19055339 |
| Lot Number | 463296 |
| Device Expiration Date | 2017-12-01 |
| Device Availability | R |
| 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 | 2015-12-11 |