MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-04-23 for T305 BIO-COOL ATC COLD THERAPY UNIT 01 manufactured by Deroyal Inc..
[189863]
A pt claims that the lower, left quadrant of their back was burned where the cold therapy unit touched their skin. The deroyal cold therapy unit with deroyal pad was applied after surgery by the nurse at 4 pm on the day before the event date. The pt, who is also a nurse, wore the pad constantly for the next 17 hours. While pt stated that pt unplugged the device at a rate of approx every 2 hours, pt did fail to remove the cooling pad and check the condition of their as the instructions for the device advise to be done frequently. On the morning of the event date, the pt felt minor discomfort not in the area of the surgical incision. When pt touched the area "a handful of skin" came off from the area of their back where the tubing touched their skin. Pt self administered burn cream and wound dressing for 9 days until would healed. Pt denied seeking treatment from physician because pt felt competent to administer care to self. Pt does not expect any permanent injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055236-2001-00001 |
| MDR Report Key | 328693 |
| Report Source | 07 |
| Date Received | 2001-04-23 |
| Date of Report | 2001-04-23 |
| Date of Event | 2001-03-03 |
| Date Facility Aware | 2001-03-23 |
| Report Date | 2001-04-23 |
| Date Reported to FDA | 2001-04-23 |
| Date Mfgr Received | 2001-03-23 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2001-04-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA PARKER |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621324 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T305 BIO-COOL ATC COLD THERAPY UNIT |
| Generic Name | TT1 EQUIPMENT |
| Product Code | IMF |
| Date Received | 2001-04-23 |
| Returned To Mfg | 2001-03-23 |
| Model Number | 01 |
| Catalog Number | T305 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 318065 |
| Manufacturer | DEROYAL INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | 88-000201 ADULT G/PAD MONO ADHESIVE |
| Baseline Generic Name | 7E2 GROUNDING PADS |
| Baseline Model No | 01 |
| Baseline Catalog No | 88-000201 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-23 |