MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-14 for ICY HOT 3 INCH ROLL manufactured by Chattem Inc.
[21412127]
Applied product per prescribed label. When removing product, the product proceeded to remove 6 inches of skin almost down to the bone. Injury bled profusely for approx 3-4 days. I was informed by (b) (4) that they had to also file a report because of injury severity. Applied icy hot 3 inch medicated roll as prescribed. When removing the product, it removed 6 inches of my skin & a great portion of body matter. (photo's were sent to (b) (4) approx 1 1/2 weeks after incident) it was not in my home state when this occurred. Not having means to go to a hospital, i applied a field dressing for the next 3-4 days to avoid infection or many other complications. (b) (4) advised me they also filed a report with the fda because my injuries required or were sufficient enough to file a claim. Dose or amount: 6 inches. Frequency: once. Dates of use: (b) (6) 2010. Diagnosis or reason for use: knee pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016349 |
| MDR Report Key | 1726736 |
| Date Received | 2010-06-14 |
| Date of Report | 2010-06-04 |
| Date of Event | 2010-04-20 |
| Date Added to Maude | 2010-06-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICY HOT 3 INCH ROLL |
| Generic Name | ICY HOT |
| Product Code | OMW |
| Date Received | 2010-06-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTEM INC |
| Manufacturer Address | 1715 WEST 38TH ST CHATTANOOGA TN 37409 US 37409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-14 |