MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for NOVII 107-PT-004 manufactured by Monica Healthcare Limited.
[85625672]
Patient Sequence No: 1, Text Type: N, H10
[85625673]
The patient was using the monica novii device for fetal monitoring. When the patches were removed, there was an open and abraded area under each of the four patches on the patient's abdomen. Two of the areas were weeping and required a dressing. The wounds were approximately 3 cm x 3 cm each. Scratch marks were visible from the use of the 3m red dot trace prep, which was used prior to patch placement. The peel and stick pads were adhered around 10:30 a. M. And removed around 10 p. M. In follow up, the nurse manager reviewed the novii patch instructions, which indicates to inform the patient that the patch may cause skin irritation and to report any pain or burning at the skin site where the patch is used. This information was discussed with the team members involved and this process was reviewed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6854498 |
| MDR Report Key | 6854498 |
| Date Received | 2017-09-11 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-08-26 |
| Report Date | 2017-08-30 |
| Date Reported to FDA | 2017-08-30 |
| Date Reported to Mfgr | 2017-08-30 |
| Date Added to Maude | 2017-09-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | NOVII |
| Generic Name | UTERINE ELECTROMYOGRAPHIC MONITOR |
| Product Code | OSP |
| Date Received | 2017-09-11 |
| Model Number | 107-PT-004 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONICA HEALTHCARE LIMITED |
| Manufacturer Address | DARRELL LYNDSEY 3862 BRENTVIEW PL NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Other | 2017-09-11 |