FDA Adverse Event
Other
Summary report: N
210 MEDI - TRACE 10/PK 500/CA
MDR report key: 2619029
·
Received June 7, 2012
Report
- Report Number
- 9681860-2012-00005
- Event Type
- Other
- Date Received
- June 7, 2012
- Report Date
- May 9, 2012
- Manufacturer
- COVIDIEN
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A MONITORING ELECTRODE. THE CUSTOMER REPORTS THAT THE PT CALLED TO REPORT A REACTION FROM THE ELECTRODE. THE PT REPORTED REDNESS, ITCHING, RASH, DRY/FLAKING SKIN, PEELING SKIN AND WELTS. THE PT REPORTED SEEKING TREATMENT FOR THE IRRITATION AND WAS SEEN BY A MEDICAL PROFESSIONAL WHO DIAGNOSED THE RASH. THE CUSTOMER REPORTS THE DIAGNOSIS WAS THAT THE RASH POSSIBLE CAUSED AN INFECTION AND ENLARGED LYMPH NODES. THE CUSTOMER WAS PRESCRIBED DOXYCYCLINE FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 210 MEDI - TRACE 10/PK 500/CA | MONITORING ELECTRODE | DRX | COVIDIEN | 31499224 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |