MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-07-01 for NON-REBREATHER OXYGEN MASK, ADULT 108MM manufactured by Unomedical S.a De C.v..
[48714539]
Based on the available information, this event is deemed to be a reportable malfunction. No patient harm was reported. No patient information was provided due to (b)(6) privacy laws. 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: july 01, 2016. (b)(4). Note: a total of two cases are associated with this complaint. A separate fda form 3500a has been completed for that case.
Patient Sequence No: 1, Text Type: N, H10
[48714540]
Complaint received from a distributor reporting that "the tube break off from the mask. This occurs the oxygen desaturation for the patient. " photos were received depicting the reported product complaint.
Patient Sequence No: 1, Text Type: D, B5
[49506554]
Expiration date (08/2019). The used product sample received was disposed of and no evaluation could be performed due to contamination upon receipt. Should additional information become available, a follow-up report will be submitted. No additional patient/event details have been provided to date. However, this issue will be monitored through the post market product monitoring review process. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63551392]
A preliminary evaluation of the reported cases were reviewed collectively due to similar failure modes reported for tubing disconnecting from mask. These complaints included a review of complaints reported between october 27, 2014 to october 27, 2016 (2 year period) for this failure. Additionally, the last product monitoring reviews (pmrs) were also reviewed and no trends were identified. 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 december 27, 2016.
Patient Sequence No: 1, Text Type: N, H10
[69129600]
This supplemental report is being submitted to correct the mfr report# for follow-up report#01 to 9680866-2016-00076, which was transcribed incorrectly during submission on january 05, 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 harms. More specifically, there were no trends observed for the oxygen masks as it relates to reported malfunction for the oxygen therapy product, (108mm). A total of eight (8) complaints were reported. 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. 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. Fda registration number: reporting site: (b)(6). Manufacturing site: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2016-00076 |
| MDR Report Key | 5766103 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-07 |
| Date Mfgr Received | 2017-02-21 |
| Device Manufacturer Date | 2014-08-13 |
| Date Added to Maude | 2016-07-01 |
| 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 | 2016-07-01 |
| Returned To Mfg | 2016-06-15 |
| Model Number | 108MM |
| Lot Number | 105987 |
| 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 | 2016-07-01 |