FDA Adverse Event
Other
Summary report: N
181 SURGI-MARK W/9 LABELS
MDR report key: 1062848
·
Received June 18, 2008
Report
- Report Number
- 1282497-2008-00020
- Event Type
- Other
- Date Received
- June 18, 2008
- Date of Event
- January 1, 2008
- Report Date
- May 26, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FZZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 6/17/08. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2008, THAT A CUSTOMER HAD A PROBLEM WITH A DEVON SURGI-MARK UTILITY MARKER. THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED INFLAMMATION UNDER THE LASIK FLAP. THE PATIENT IS BEING TREATED FOR DLK (DIFFUSE LAMELLAR KERATITIS) INFLAMMATION WITH A PRESCRIPTION OF PREFORTE 1% STEROID DROPS EVERY HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 181 SURGI-MARK W/9 LABELS | SKIN MARKER | FZZ | TYCO HEALTHCARE/KENDALL | 31145884 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |