MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-10-14 for OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT 104-E manufactured by Unomedical S.a. De C.v..
[28143040]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested; however, no further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Reported to the fda on october 13, 2015. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28143041]
It was reported the oxygen mask was placed on a patient. The oxygen was gradually increased to 10l/min. Although the tubing remained connected at the lower oxygen setting, once the oxygen was increased to 10l/min "the tube came off the facemask. " the mask was removed and a new device was used. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[30879731]
Additional information: a batch review was conducted and no discrepancies were found. There is no previous investigation available to leverage. Samples from current production lot number 104-e were checked and tested. All samples met retention requirement of 10 pounds between tube adapter and mask connector. There is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required at this time. A returned sample was expected, but not received. The investigation will be re-opened upon receipt of the complaint sample. 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
[34210341]
Additional information: a sample was received and disconnection testing performed. The tube was assembled to the mask connector without applying glue and disconnected applying a force of 5. 67 pounds. Then the tube was assembled again applying glue and disconnected applying force of 8. 75 pounds. Based on the results the complaint sample did not meet specifications. A nonconformance was opened and this complaint will remain open until the completion of the investigation. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2015-00084 |
| MDR Report Key | 5147716 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-27 |
| Date of Event | 2015-09-18 |
| Date Mfgr Received | 2015-11-20 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-10-14 |
| 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 | MR. 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 | 2015-10-14 |
| Returned To Mfg | 2015-11-12 |
| Model Number | 104-E |
| Lot Number | 112024 |
| 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 MARQUE IND. DEL NORTE REYNOSA, TAMAULIPAS 88736 MX 88736 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-14 |