MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-08-02 for PATIENT MASK MP01575 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[115763726]
The investigation has just started; results will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[115763727]
It was reported that the application of the niv mask to the patient was difficult and resulted in intermittent disturbances of ventilation. A skin injury has reportedly occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2018-00243 |
| MDR Report Key | 7741780 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-08-02 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-08-31 |
| Date Added to Maude | 2018-08-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SONJA HILLMER |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | L 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | 23542 |
| Manufacturer Phone | 451882268 |
| Manufacturer G1 | DRAEGERWERK AG & CO. KGAA |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | LUEBECK, 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 23542 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT MASK |
| Generic Name | FULL FACE MASK, NON- INVASIVE VENTILATION |
| Product Code | BSJ |
| Date Received | 2018-08-02 |
| Model Number | NA |
| Catalog Number | MP01575 |
| Lot Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR?GERWERK AG & CO. KGAA |
| Manufacturer Address | MOISLINGER ALLEE 53-55 L?BECK 23542 GM 23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-02 |