MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for MONICA HEALTHCARE FETAL MONITOR GTIN(01) 05060433670053 manufactured by Monica Healthcare Ltd..
[129780622]
The electrodes left an inflamed, reddened area where they had been previously placed on the pregnant woman's abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081891 |
| MDR Report Key | 8138801 |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-01 |
| Date Added to Maude | 2018-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONICA HEALTHCARE FETAL MONITOR |
| Generic Name | SYSTEM, MONITORING, PERINATAL |
| Product Code | HGM |
| Date Received | 2018-12-05 |
| Model Number | GTIN(01) 05060433670053 |
| Lot Number | (10) 500871 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONICA HEALTHCARE LTD. |
| Manufacturer Address | NOTTINGHAM NG105QG UK NG10 5QG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-05 |