FDA Adverse Event
Injury
Summary report: N
NISSHA MEDICAL TECHNOLOGIES
MDR report key: 16550663
·
Received March 15, 2023
Report
- Report Number
- 1317188-2023-00005
- Event Type
- Injury
- Date Received
- March 15, 2023
- Date of Event
- December 6, 2022
- Report Date
- March 15, 2023
- Manufacturer
- MEDICO ELECTRODES INTERNATIONAL LTD
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A LOT NUMBER WAS NOT PROVIDED. A DHR REVIEW COULD NOT BE COMPLETED WITHOUT A LOT NUMBER TO TRACE BACK WITH. BIOCOMPATABILITY REPORTS SHOW THE SKIN CONTACTING MATERIALS ARE NON-CYTOTOXIC, NON-SENSITIZING, AND NON-IRRITATING. NO FURTHER INVESTIGATION CAN BE PERFORMED WITH THE LIMITED INFORMATION. THE IMPORTER REPORTS THIS EVENT IN AN ABUNDANCE OF CAUTION DUE TO THE PATIENT CONSULTING A CLINICIAN AND BEING PRESCRIBED MEDICATION FOR THE BLISTER.
Description of Event or Problem · 0
THE PATIENT REPORTED RED, ITCHY SKIN WITH RAW RED BLISTER/BUMPS. THE PATIENT PREPPED THEIR SKIN USING THE UNIVERSAL SKIN PREP. THE PATIENT WAS USING LWA/VERMED ELECTRODES AT THE TIME OF SKIN IRRITATION. THE PATIENT WENT TO URGENT CARE AND WAS PRESCRIBED CREAM/NEOSPORIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 496294 | NISSHA MEDICAL TECHNOLOGIES | ECG MONITORING ELECTRODE | DRX | MEDICO ELECTRODES INTERNATIONAL LTD | A10091-30 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Unknown | Other |