MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-16 for ICY HOT PRO-THERAPY BACK BRACE 1811A manufactured by Chattem, Inc..
[16919159]
Consumer reported that he developed a rash on stomach from use of product. (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[16936883]
This report is below the threshold of the fda's requirements for mandatory reporting of adverse events involving medical devices as there is no evidence that use of the product resulted in serious adverse health consequences. Accordingly, this mdr is being submitted as a voluntary and proactive measure by the manufacturer to enhance product safety and pharmacovigilance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022556-2009-00172 |
| MDR Report Key | 1532763 |
| Report Source | 04 |
| Date Received | 2009-11-16 |
| Date of Report | 2007-03-20 |
| Date Mfgr Received | 2007-03-20 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2010-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID GROB |
| Manufacturer Street | 1715 WEST 38TH ST. |
| Manufacturer City | CHATTANOOGA TN 37409 |
| Manufacturer Country | US |
| Manufacturer Postal | 37409 |
| Manufacturer Phone | 4238223370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICY HOT PRO-THERAPY BACK BRACE |
| Product Code | IQE |
| Date Received | 2009-11-16 |
| Returned To Mfg | 2007-04-12 |
| Model Number | 1811A |
| Lot Number | 06A404 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTEM, INC. |
| Manufacturer Address | CHATTANOOGA TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-16 |