MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOOD I002610 manufactured by Unomedical Sa De Cv.
[30722401]
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 21 cfr 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
[30722402]
Customer reported that the whistle sound was heard from the connection between the oxygen and the flowmeter, so the device was changed to the new one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2015-31375 |
| MDR Report Key | 5204466 |
| Date Received | 2015-11-05 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-10-22 |
| 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 | 0 |
| Brand Name | ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOOD |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATION, VENTURI |
| Product Code | BYF |
| Date Received | 2015-11-05 |
| Returned To Mfg | 2014-11-12 |
| Model Number | I002610 |
| 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 |