FDA Adverse Event
Injury
Summary report: N
SEEQ
MDR report key: 7091259
·
Received December 7, 2017
Report
- Report Number
- 3010824444-2017-00009
- Event Type
- Injury
- Date Received
- December 7, 2017
- Date of Event
- October 27, 2017
- Report Date
- December 6, 2017
- Manufacturer
- EPIC TECHNOLOGIES, LLC
- Product Code
- DSI
- PMA / PMN Number
- K133701
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT REMOVED THE WEARABLE SENSOR THE SKIN HAD RED BUMPS AND A FEW CONTAINED PUS; THE AREA WAS ALSO SORE. THE PATIENT DID NOT APPLY A NEW SENSOR. IT IS UNKNOWN IF THE SENSOR WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 873018 | SEEQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | EPIC TECHNOLOGIES, LLC | MMI-SENSOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |