MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-03-07 for OXYGEN MASK NON-REBR ADLT 3106-E manufactured by Unomedical S. A. De C.v.
[39844776]
On (b)(6) 2018. On (b)(6) 2013. Based on the available information, this event is deemed to be a reportable malfunction. On (b)(6) 2016: no previous investigations are available to leverage. Detailed review of batch records for product and lot showed no discrepancies (including non-conformances/deviations). The evaluation of two (2) returned samples indicated that the reservoir bags had cuts/tears on them. The type of cuts/tears indicates that it could be caused during manipulation of devices in their use. It is highly unlikely that it could be a failure attributed to the manufacturing process. Based on the investigation results, it can be considered as an isolated quality issue that does not require any additional action. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required and the complaint will be closed. No additional details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4). Note: this complaint issue occurred in four (4) separate cases. Separate 3500a forms have been completed for the cases.
Patient Sequence No: 1, Text Type: N, H10
[39844777]
Complaint received from a distributor reporting issues with the oxygen reservoir on the product. Reporter stated "there are four (4) defective items, plastic balloon where it inflates has holes and oxygen escapes. " there were no reports of patient use or patient harm. No further details were provided by the reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2016-00070 |
| MDR Report Key | 5484753 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-03-07 |
| Date of Report | 2016-02-11 |
| Date Mfgr Received | 2016-02-11 |
| Date Added to Maude | 2016-03-07 |
| 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 | OXYGEN MASK NON-REBR ADLT |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-03-07 |
| Returned To Mfg | 2016-02-24 |
| Model Number | 3106-E |
| Lot Number | 13-32 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-03-07 |