MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-09-28 for MEDIUM CONCENTRATION MASK, ADULT, 2.1M PMD06104 manufactured by Unomedical S.a De C.v..
[55883776]
Based on the available information, this event is deemed to be a reportable malfunction. Additional details have been requested but not provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55883777]
Complaint reporting oxygen tubing seemed to be blocked on opening this meant no oxygen could flow through. Staff needed to open another pack. No further information was provided including patient outcome or usage of the device.
Patient Sequence No: 1, Text Type: D, B5
[65930909]
The last three (3) product monitoring reviews (pmrs) were reviewed and none of the affected product codes have illustrated any trends for product category or any malfunction or any harm. More specifically, there were no trends observed for oxygen masks. Complaints spanning from october 27, 2014, through october 27, 2016 (2 years) were reviewed as it related to reports of nozzle issues. A total of three (3) complaints were reported from a single complaint. No trends were observed and no harms reported. In all cases, the product was discontinued and replaced. Complaints spanning from october 27, 2014, through october 27, 2016 (2 years) were reviewed as it related to reports of blocked oxygen tubing. A total of one (1) complaint was reported. No trends were observed and no harms reported. In all cases, the product was discontinued and replaced. These issues will be monitored through the post market product monitoring review process. No additional patient/event details have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on january 13, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2016-00089 |
| MDR Report Key | 5984396 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-05 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2016-09-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDIUM CONCENTRATION MASK, ADULT, 2.1M |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-09-28 |
| Model Number | PMD06104 |
| Lot Number | 118656 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-09-28 |