MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-07-11 for NON-REBREATHER OXYGEN MASK, ADULT 108MM manufactured by Unomedical Sa De Cv.
[49237957]
Based on the available information, this event is deemed to be a reportable malfunction. No patient harm was reported. Additional details have been requested but not provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4). Note: a total of three (3) cases are associated with this complaint.
Patient Sequence No: 1, Text Type: N, H10
[49237958]
Complaint received from a distributor reporting that "the tube break off from the mask. This occurs the oxygen de-saturation for the patient. " the issue was noted at the fixation between the mask and the tube. Photos were received depicting the reported product complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2016-00081 |
| MDR Report Key | 5783841 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-07-11 |
| Date of Report | 2016-07-08 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2016-07-11 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| 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 | NON-REBREATHER OXYGEN MASK, ADULT |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-07-11 |
| Model Number | 108MM |
| Lot Number | 103691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-07-11 |