MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-12 for MOIST HOT PACK 1006 manufactured by Chattanooga Group.
[922204]
Clinician was treating pt for upper back and shoulder pain with a hot pack when the heat pac leaked onto the pt. The pt was lying face down and he clinician applied the standard hot pac to the treatment area. The pac was wrapped in 3 large towels. Within a few seconds the gel and some of the hot water from the pac started running down and around the pt's neck. The pt received a burn from the leak. The pt had bright red stripes down both sides of neck where the hot fluid had traveled. The burn area dis blister up. The clinician applied antiseptic on the burns and sent the pt home. Within the hour the pt was still hurting from the burn. The pt reported to an urgent care facility for additional treatment. The burn area did blister up.
Patient Sequence No: 1, Text Type: D, B5
[8264312]
The customer disposed of the device and could not return the device for evaluation. An evaluation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00253 |
| MDR Report Key | 1159103 |
| Report Source | 05 |
| Date Received | 2008-09-12 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-08-14 |
| Date Mfgr Received | 2008-08-14 |
| Date Added to Maude | 2008-09-17 |
| 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 | 3 |
| 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 | MOIST HOT PACK |
| Product Code | IMA |
| Date Received | 2008-09-12 |
| Model Number | 1006 |
| Catalog Number | 1006 |
| 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 | 1182817 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-12 |