MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2008-10-21 for BABYFLOW manufactured by Draeger Medical Ag & Co. Kg.
[979978]
It was reported that: "baby, was installed in the nasal-flow cpap system. Prior to suctioning baby's nares, cpap tube was removed, bruising of the septum was noted as well as some bloody discharge, and redness around the nares. Immediate consequences to the patient: physical - redness with skin breakdown and small amount of bleeding. Septum of baby fell off. "
Patient Sequence No: 1, Text Type: D, B5
[8209411]
Prongs were 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 | 9611500-2008-00034 |
| MDR Report Key | 1203014 |
| Report Source | 01,07 |
| Date Received | 2008-10-21 |
| Date of Report | 2008-10-07 |
| Date of Event | 2008-09-13 |
| Date Mfgr Received | 2008-09-28 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2008-10-24 |
| 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 D-23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-23542 |
| Manufacturer Phone | 518822868 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BABYFLOW |
| Generic Name | NEONATAL NASAL FLOW CPAP SYSTEM |
| Product Code | NHJ |
| Date Received | 2008-10-21 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 8004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1251449 |
| Manufacturer | DRAEGER MEDICAL AG & CO. KG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-21 |