MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-25 for E-CARDIO ER920W manufactured by E-cardio.
[3131652]
Pt received the device in (b)(6) 2011, ordered by her physician to be worn for 10 days. The first monitor stopped working right after she left the doctor's office. Pt was given another monitor with latex free leads because of her severe allergies. On (b)(6) 2011, she called the manufacturer because she had started experiencing burning from the leads. She was seen at the emergency room with a diagnosis of chemical burns, scarring on chest and abdomen. She was referred to a plastic surgeon who prescribed bleaching creams for her scars. Pt is in pain, insomnia and is seeking compensation from the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029129 |
| MDR Report Key | 2980710 |
| Date Received | 2013-02-25 |
| Date of Report | 2013-02-25 |
| Date of Event | 2011-11-03 |
| Date Added to Maude | 2013-02-28 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-CARDIO |
| Generic Name | HOLTER MONITOR |
| Product Code | MWJ |
| Date Received | 2013-02-25 |
| Model Number | ER920W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-CARDIO |
| Manufacturer Address | 1717 N. SAM HOUSTON PKWY HOUSTON TX 77038 US 77038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-02-25 |