MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-10-08 for HEADGEAR manufactured by Drager Medical Ag & Co. Kg.
[1172323]
It was reported that during use of the head gear for mask fixation the patient received 2nd degree burns on the face which healed spontaneously. The event already happened in 2009, mfr has been informed on september 17th, 2009. The patient fully recovered and went home.
Patient Sequence No: 1, Text Type: D, B5
[8420245]
The investigation is ongoing, the results will be part of the follow up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611500-2009-00030 |
| MDR Report Key | 1496713 |
| Report Source | 05,06,07 |
| Date Received | 2009-10-08 |
| Date of Report | 2009-09-25 |
| Date of Event | 2009-06-09 |
| Date Mfgr Received | 2009-09-17 |
| Date Added to Maude | 2009-10-13 |
| 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 | 518822868 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEADGEAR |
| Generic Name | VENTILATION MASK FIXATION |
| Product Code | BSJ |
| Date Received | 2009-10-08 |
| Model Number | NA |
| Catalog Number | NA |
| 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 | DRAGER MEDICAL AG & CO. KG |
| Manufacturer Address | MOISLINGER ALLEE 53-55 LUEBECK D-23542 D-23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-10-08 |