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 2018-04-06 for CALEO 2M50555 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[104553641]
The investigation was started but is not yet concluded. The investigation result will be reported in a follow up-report.
Patient Sequence No: 1, Text Type: N, H10
[104553642]
It was reported by the user facility that in the frame of an enquiry for bacillus cereus control positive samples have been found. Since (b)(6) 2018, 4 infected babies, one death. However detailed information of the cause of death and infections was not yet provided and is still under assessment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2018-00098 |
| MDR Report Key | 7402383 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-06 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2013-10-31 |
| Date Added to Maude | 2018-04-06 |
| 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 | 4518822868 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALEO |
| Generic Name | INCUBATOR, INFANT |
| Product Code | FMZ |
| Date Received | 2018-04-06 |
| Model Number | NA |
| Catalog Number | 2M50555 |
| Lot Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DR?GERWERK AG & CO. KGAA |
| Manufacturer Address | MOISLINGER ALLEE 53-55 L?BECK 23542 GM 23542 |
| Brand Name | CALEO |
| Generic Name | INCUBATOR, INFANT |
| Product Code | FMZ |
| Date Received | 2018-04-06 |
| Model Number | NA |
| Catalog Number | 2M50555 |
| Lot Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2018-04-06 |