MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2015-11-09 for OXYGEN ADJFOAM 10/040CM/74BL8O + 19030182 manufactured by Unomedical S.r.o..
[30686858]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Blank fields on this form indicate the information is unknown, unavailable or unchanged. 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
[30686859]
Complainant reports "anomaly of packaging oxygen probes" (product caught in sterile package seal).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2015-31237 |
| MDR Report Key | 5209924 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2015-11-09 |
| Date of Report | 2014-02-27 |
| Date of Event | 2011-06-24 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-11-09 |
| 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 | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN ADJFOAM 10/040CM/74BL8O + |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2015-11-09 |
| Returned To Mfg | 2011-09-21 |
| Model Number | 19030182 |
| Lot Number | 401942 |
| Device Expiration Date | 2016-03-01 |
| 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 | 2015-11-09 |