MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-09-11 for CLASSIC STAR VENTILATION MASK (SINGLE USE) MP01574 manufactured by Draeger Medical Ag & Co. Kg.
[17468344]
It was reported that: significant sores to bridge of nose and at times to the side of the face despite staff applying a protective dressing to the skin of the nose before commencement of treatment.
Patient Sequence No: 1, Text Type: D, B5
[17640482]
The concerned mask was requested for investigation but not yet received. Investigation results will be reported in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611500-2009-00029 |
| MDR Report Key | 1515724 |
| Report Source | 01,07 |
| Date Received | 2009-09-11 |
| Date of Report | 2009-09-10 |
| Date of Event | 2009-08-17 |
| Date Mfgr Received | 2009-09-03 |
| Date Added to Maude | 2009-10-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK CLANZETT |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | LUEBECK 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | 23542 |
| Manufacturer Phone | 518822858 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC STAR VENTILATION MASK (SINGLE USE) |
| Generic Name | NON-INVASIVE VENTILATION MASK |
| Product Code | BSJ |
| Date Received | 2009-09-11 |
| Model Number | NA |
| Catalog Number | MP01574 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL AG & CO. KG |
| Manufacturer Address | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-11 |