MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-21 for D-3 HYDROCOLLATOR HEATING UNIT manufactured by Chattanooga Group.
[16715974]
(b)(4). The incident occurred on (b)(6) 2008. The clinician treated a patient for lower back pain using a standard hot pac pack. The clinician wrapped the hot pac in the hot pac's mfg standard accessory terry cloth wrap. The clinician then applied the hot pac to the patients lower back. Paper toweling was applied between the patient and the wrapped hot pac in effort to absorb any potential excess fluid. The patient remained positioned and unattended for the duration of the heat therapy treatment, 15 minutes. The patient did not note any treatment discomfort. Upon completion of the treatment the clinician noted a 3 inch area in the area of treatment that immediately began to blister and show the signs of a second degree burn. The patient had received heat therapy from this clinician on previous occasions with no incidents. The clinician had treated other patients with the same ascribed configuration without incident. The hot pac heating device did not show any immediate or previous signs of malfunction. Critical to the correct application of the heat therapy is the water temperature of the hot pac heating device. The fundamental performance of the heat therapy is to heat the hot pac via a water medium in a source device. The clinician had checked the source device water temperature the previous week. The clinician could not give the exact day that the water temperature was checked. The clinician did indicate that the typical operating temperature of the source device is 130 degrees f. The clinician removed the heating device from service. The device will be evaluated by the manufacture.
Patient Sequence No: 1, Text Type: D, B5
[16907611]
Awaiting return and evaluation of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00099 |
| MDR Report Key | 1016327 |
| Report Source | 05 |
| Date Received | 2008-03-21 |
| Date of Report | 2008-03-17 |
| Date of Event | 2008-01-25 |
| Date Added to Maude | 2012-12-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-3 HYDROCOLLATOR HEATING UNIT |
| Generic Name | 890.5730 MOIST HEAT PACK |
| Product Code | IMA |
| Date Received | 2008-03-21 |
| Model Number | D-3 |
| Catalog Number | D-3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-21 |