MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-04 for OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT 86-108E 543538 manufactured by Unomedical Sa De Cv.
[70371535]
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).
Patient Sequence No: 1, Text Type: N, H10
[70371537]
Complaint reporting "mask does not allow patient to breathe correctly. It is cutting off air with deep breaths. " no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[73355633]
This supplemental report is being submitted to correct the mfr report# for follow-up report#01 to 9680866-2016-00092, 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 harms. More specifically, there were no trends observed for the oxygen masks. Complaints spanning october 27, 2014 to october 27, 2016 (2 years) were reviewed as it related to reports of poor performance and cutting off oxygen flow, total of one (1) complaint was reported. No trends were observed and 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 march 21, 2017. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2016-00092 |
| MDR Report Key | 5201145 |
| Report Source | OTHER |
| Date Received | 2015-11-04 |
| Date of Report | 2016-09-09 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2015-11-04 |
| 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 |
| Manufacturer G1 | CONVATEC |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2015-11-04 |
| Model Number | 86-108E 543538 |
| Lot Number | 052616N02 |
| 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 | 2015-11-04 |