FDA Adverse Event
Injury
Summary report: N
MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
MDR report key: 8876010
·
Received August 8, 2019
Report
- Report Number
- 2133409-2019-00001
- Event Type
- Injury
- Date Received
- August 8, 2019
- Report Date
- August 8, 2019
- Manufacturer
- BRAEMAR MANUFACTURING, LLC
- Product Code
- DSI
- UDI-DI
- B146C6S0
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BRAEMAR MANUFACTURING IS NO LONGER INVESTIGATING THIS INCIDENT AND CONSIDERS THIS MATTER CLOSED.
Description of Event or Problem · 1
ON (B)(6) 2019, BRAEMAR MANUFACTURING, LLC WAS MADE AWARE OF PATIENT ALLEGATION OF BURN/SKIN REACTION. THE PATIENT ALLEGEDLY WORE A C6 PATCH MONITOR IN EVENT MODE AND INDICATED THAT HER SKIN REACTED ADVERSELY TO THE MONITOR AND THAT SHE EXPERIENCED A SKIN BURN. THE PATIENT INDICATED THAT SHE DID NOT EXPERIENCE AN ADVERSE EVENT WHEN SHE WORE THE FIRST PATCH AND THAT THE EVENT OCCURRED DURING THE SECOND WEEK OF USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669861 | MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) | MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) | DSI | BRAEMAR MANUFACTURING, LLC | 900-0634-00 | B146C6S0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |