MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-12-22 for PORTEX ? FIRST BREATH ADULT TRACHEOSTOMY MASK 001305 manufactured by Smiths Medical Asd, Inc..
[63194288]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63194289]
It was reported that the patient experienced pressure wounds from the tracheostomy mask since the product material has changed to a more solid material. It is unknown whether the event has been resolved, however, it was reported that the patient was changed to a competitor's brand. No further adverse health outcomes have been reported. See mfr: 3012307300-2016-00593.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2016-00595 |
| MDR Report Key | 6201007 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-01 |
| Date Mfgr Received | 2016-12-01 |
| Date Added to Maude | 2016-12-22 |
| 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 | MS. LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 9124 POLK LANE SUITE 101 |
| Manufacturer City | OLIVE BRANCH MS 38654 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38654 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX ? FIRST BREATH ADULT TRACHEOSTOMY MASK |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-12-22 |
| Catalog Number | 001305 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |