MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-10-26 for OXYGEN MASK ADULT 108-E manufactured by Unomedical S.a. De C.v..
[29273731]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[29273732]
It was reported the tubing is disconnected from the masks when the tubes were connected to an oxygen tank. The masks were removed and replaced with new masks. The initial reporter was unable to determine the number of devices or patients impacted. It was further reported the tubes appeared to be poorly welded/glued to the mask. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2015-00107 |
| MDR Report Key | 5178520 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-10-05 |
| Date Added to Maude | 2015-10-26 |
| 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 | MATTHEW WALENCIAK |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Manufacturer G1 | CONVATEC |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN MASK ADULT |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2015-10-26 |
| Model Number | 108-E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.A. DE C.V. |
| Manufacturer Address | AV. INDUSTRIAL FALCON, LOTE 7 PARQUE IND. DEL NORTE REYNOSA, TAMAULIPAS 88736 MX 88736 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-26 |