MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-07-10 for THERMOTEX THERAPY SYSTEMS TTS PLATINUM manufactured by Thermotex Therapy Systems Ltd..
[2835500]
(b)(6) contacted us to say he had used his tts platinum pad for about 20 minutes. He said it did not feel hot at the time of use, but later that night or the next morning, his wife noticed a blister about the size of a 50 cent piece. He asked if we would send him a replacement heating pad. (b)(6) suffers from sciatica and was treating pain that radiates down to his lower leg. He was treating the lower portion of his left leg. The blister appeared on the outside of his leg approximately 8" above his ankle. He did go to his doctor to get an ointment to treat it. The medical records were not supplied.
Patient Sequence No: 1, Text Type: D, B5
[10054279]
Physical inspection of the returned tts platinum showed no unusual wear on the outer cover and each heat insert appeared to be in good condition. Several tests were performed measuring the temperatures of each heat insert over a period of time using a fluke 54 ii thermometer. In one particular test that was performed on each heat insert, temperatures were measured at one minute intervals for 499 minutes, the heat inserts were set at the high setting. This same test was performed with the heat inserts set on the low setting. Temperatures for both tests (high and low settings) were found to be well within set parameters. Another series of tests were performed measuring the temperatures (in one minute intervals) over a period of 20 minutes on the high setting just as bb described he used the product before the adverse event occurred. The maximum temperature reached during this time period was 53 degrees celsius with the average temperature over the 20 minute period being 41. 78 degrees celsius. In conclusion, the tts platinum was found to be working within specifications, no failures were detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615330-2012-00001 |
| MDR Report Key | 2661249 |
| Report Source | 04 |
| Date Received | 2012-07-10 |
| Date of Report | 2012-07-10 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2012-06-15 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2012-07-20 |
| 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 | WENDY DOCHERTY |
| Manufacturer Street | 15, 6115 - 4 ST. S.E. |
| Manufacturer City | CALGARY, AB T2H 2H9 |
| Manufacturer Postal | T2H 2H9 |
| Manufacturer Phone | 2525335 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOTEX THERAPY SYSTEMS |
| Generic Name | THERMOTEX |
| Product Code | ILY |
| Date Received | 2012-07-10 |
| Returned To Mfg | 2012-06-15 |
| Model Number | TTS PLATINUM |
| Lot Number | 262 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMOTEX THERAPY SYSTEMS LTD. |
| Manufacturer Address | 15, 6115 - 4 ST. S.E. CALGARY, AB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-10 |