MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for CAREONE manufactured by Unk.
[185938675]
Caller stated she began to experience negative reactions after using device and starting medications. Symptoms include: physical imbalance, falling, rash over stomach and chest, erythema, itching, tiny ulcers under skin, burning sensation, and vision impairment. She is unable to perform activities of daily living and maintain her job.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093983 |
| MDR Report Key | 9903199 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2018-03-01 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | CAREONE |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2020-03-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | CAREONE |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2020-03-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |