MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-15 for SS-2 120V W/PAKS 2302 manufactured by Chattanooga Group.
[991028]
The patient reported redness and discomfort after being treated with a hot pac. The patient did not require medical attention for the incident, nor was his progression impeded. The hot pac had been heated in a hydrocollator heating device. The clinician reported that the device water temperature was at 160 degrees f and stable. After the alleged injury, the device was monitored for seven days. At no time during the seven days did the device fail to maintain the temperature of 160 degrees f or operate in an unstable fashion. The clinician did share that the patient was potentially hyper-sensitive to heat.
Patient Sequence No: 1, Text Type: D, B5
[8136361]
Awaiting device return and evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00355 |
| MDR Report Key | 1266228 |
| Report Source | 05 |
| Date Received | 2008-12-15 |
| Date of Report | 2008-11-18 |
| Date of Event | 2008-10-28 |
| Date Mfgr Received | 2008-11-18 |
| Date Added to Maude | 2009-01-13 |
| 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 | MR. 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 | SS-2 120V W/PAKS |
| Product Code | IRQ |
| Date Received | 2008-12-15 |
| Model Number | 2302 |
| Catalog Number | 2302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2008-12-15 |