MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-10-28 for VENTURI MASK KIT ADULT 120A-MM manufactured by Unomedical Sa De Cv.
[58770486]
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. Reported to the fda on october 28, 2016. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58770487]
Complaint reporting that "the connector presented diameter too small causing turbulence and whistle when administering oxygen. The problem is that this mask provides different ranges of adjustment, which can not be used, since the whistle begins. Of the six (6) levels can be used only two (2). Normally this mask should be adjusted to 50%; but due to the problem, it is used to 28% or should be manipulated. " the reported issue was noted immediately and the device was removed and discontinued. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[65847209]
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 the 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 complainant. No trends were observed. No harms reported. In all cases, the product was discontinued and replaced. This issue 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 20, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2016-00094 |
| MDR Report Key | 6064188 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2016-10-28 |
| 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 |
| 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 | VENTURI MASK KIT ADULT |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATION, VENTURI |
| Product Code | BYF |
| Date Received | 2016-10-28 |
| Model Number | 120A-MM |
| Lot Number | 114091 |
| 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 | 2016-10-28 |