MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-15 for STEAM PAC STANDARD BOXED manufactured by Chattanooga Group.
[917406]
A female patient received a burn during the use of a hot pack. The patient was being treated on the right hip for hip pain. The patient was placed on their left side for the treatment. The clinician applied the hot pac to the patient's right hip. The pack was wrapped in six layers of toweling and applied to the patient. The patient indicated to the clinician that they felt a hot area on their left side. The clinician that they felt a hot area on their left side. The clinician terminated the treatment, and inspected the treatment area and the patient's left side. The patient's left side had a red mark about 1 inch in diameter. The mark on the left side did appear to be a 2nd degree burn. A patient's right side had no markings from the application of the treatment. The clinician did render first aid to the patient with the use of antiseptic and gauze. The patient did follow up with their primary care physician. Upon inspection of the hot pack, the clinician noted that the pack seam had split. The clinician indicated that the split in the seam allowed the contents of the pack to leak onto the treatment surface, coming into contact with the patient's left side.
Patient Sequence No: 1, Text Type: D, B5
[8263315]
The clinic could not determine the model number of the device. The clinic disposed of the device. The device was not returned to the manufacture for evaluation. The manufacture could not determine the root cause and/or conditions that lead to the device's reported failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00256 |
| MDR Report Key | 1161193 |
| Report Source | 05 |
| Date Received | 2008-09-15 |
| Date of Report | 2008-08-20 |
| Date of Event | 2007-08-20 |
| Date Mfgr Received | 2008-08-20 |
| Date Added to Maude | 2008-09-22 |
| 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 | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS ROAD |
| 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 | STEAM PAC STANDARD BOXED |
| Product Code | IMA |
| Date Received | 2008-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1188699 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-15 |