MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-09-28 for NON-REBREATHING OXYGEN MASKS 9108MM manufactured by Unomedical S. A. De C.v.
[55879773]
Expiration date: 06/01/2019. Device/mfr date: 06/01/2014. 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). A total of two cases associated with this complaint.
Patient Sequence No: 1, Text Type: N, H10
[55879774]
Complaint reporting, "for almost all masks the oxygen tube is tearing and falls off. Therefore the patient is not receiving oxygen anymore and could suffocate. " no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[63928243]
Product sample received. It was confirmed that the product samples were: (5) oxygen therapy, high concentration oxygen masks, non-rebreathing mask, adult, standard connector. Product was unused and could not determine malfunction from visual inspection. Product stored until further notice. No additional patient/event details have been 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
[68985023]
This supplemental report is being submitted to correct the mfr report# for follow-up report#01 to 9680866-2016-00091, which was transcribed incorrectly during submission on january 19, 2017 in error. 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 to october 27, 2016 (2 years) were reviewed as it related to reports for the oxygen therapy products. A total of twenty-eight (28) complaints were reported. No trends were observed. However, there was one (1) non-conformance opened to investigate reports of tubing disconnecting from the oxygen therapy masks from various lot numbers. The non-conformance identified possible root causes as: inadequate assembly work instructions, and inadequate solvent dispenser. Corrective actions were implemented to correct the solvent gluing of the tubing to the masks by december, 2015. After review, this complaint has a batch that was made prior to corrective actions for the disconnecting tubing. No complaints after the corrective actions have been received for the affected products. No further action is required for investigation of this complaint. 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 february 23, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2016-00091 |
| MDR Report Key | 5984638 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-09 |
| Date Mfgr Received | 2017-02-21 |
| 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 |
| 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-REBREATHING OXYGEN MASKS |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-09-28 |
| Returned To Mfg | 2016-12-12 |
| Model Number | 9108MM |
| Lot Number | 104848 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |