FDA Adverse Event
Injury
Summary report: N
OCL
MDR report key: 171960
·
Received February 5, 1998
Report
- Report Number
- MW4002235
- Event Type
- Injury
- Date Received
- February 5, 1998
- Report Date
- February 5, 1998
- Manufacturer
- MEDICAL DEVICE MFG. & DISTRIBUTION
- Product Code
- FYH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING PHYSICIAN CLAIMS THAT USE OF "SUGAR TONG SPLINT" CAUSED SEVERE CONTACT DERMATITIS ON HIS PT. THE DERMATITIS WAS SO SEVERE THAT IT WAS MORE LIKE A BURN. PHYSICIAN BELIEVES THE INNER CORE MATERIAL IS PROBLEM, NOT THE FOAM. SUGAR TONG SPLINT REPORT OBTAINED WHILE AT PHYSICIAN'S OFFICE ON A RELATED COMPLAINT FOLLOW-UP. PHYSICIAN MET BRIEFLY W/INVESTIGATOR DURING A BREAK FROM SEEING PTS. HE SAID HE COULD BE CONTACTED LATER FOR ADD'L INFO. SEVERAL CALLS HAVE BEEN MADE TO HIS OFFICE, BUT HE HAS NOT RETURNED THEM. SAMPLE WILL NOT BE ANALYZED AT THIS TIME. THE SAMPLE WILL BE USED DURING THE FOLLOW-UP AT THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCL | "SUGAR LONG SPLINT" (22" LONG) | FYH | MEDICAL DEVICE MFG. & DISTRIBUTION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |