MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2015-11-05 for NON-REBREATHER OXYGEN MASK, ADULT HIGH CONCENTRATION WITH 2.1 M (7') OXYGEN TUBE 108MM manufactured by Unomedical Sa De Cv.
[30499862]
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
[30499863]
It was reported that during the preparation (test inflating) the bag burst at a rate of 15l/min.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2015-31374 |
| MDR Report Key | 5204454 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2015-11-05 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-08-27 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-11-05 |
| 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 | NON-REBREATHER OXYGEN MASK, ADULT HIGH CONCENTRATION WITH 2.1 M (7') OXYGEN TUBE |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2015-11-05 |
| Returned To Mfg | 2014-09-22 |
| Model Number | 108MM |
| Lot Number | 13-32 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL SA DE CV |
| Manufacturer Address | AV. INDUSTRIAL FALCON LOTE 7 PARQUE IND DEL NORTE REYNOSA, TAMAULIPAS 88736 MX 88736 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-05 |