MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-02-09 for HEADGEAR manufactured by Draeger Medical Ag & Co. Kg.
[1421719]
It was reported that during use of the headgear for mask fixation the pt received skin impairment in the face. Users assume that the edge of the headgear became hard and caused the injury.
Patient Sequence No: 1, Text Type: D, B5
[8455189]
Head gears of the concerned type are used to fixate ventilation masks. As the masks are disposable articles made from pvc, the head gear is made from silicone rubber and can be autoclaved. These facts are described in the masks instructions for use. Our investigation comes to the conclusion, that in the reported case the headgear was cleaned with a disinfection agent, which is not recommended in the instructions for use, but is intended to remove residues of organic material from instruments. A photo of the skin impairment revealed that there were no cuts in any way, but a damaged area of some square centimeters. With high likelihood this impairment has to be attributed to residues of the disinfection agent. This is the second case in the concerned hospital (first case reported as mdr 9611500-2009-00030), but there exist no other similar reports worldwide. As the masks of the mentioned types are sold in high numbers and the reported events are isolated, it was concluded that there exists no deficiency in the product or the instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611500-2010-00005 |
| MDR Report Key | 1618124 |
| Report Source | 06,07 |
| Date Received | 2010-02-09 |
| Date of Report | 2010-02-09 |
| Date of Event | 2010-01-18 |
| Date Mfgr Received | 2010-02-02 |
| Date Added to Maude | 2011-09-15 |
| 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 | 2010-02-09 |
| 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 | DRAEGER MEDICAL AG & CO. KG |
| Manufacturer Address | MOISLINGER ALLEE 53-55 LUEBECK D-23542 D-23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-09 |