MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-23 for M-2 HYDROCOLLATOR 2402 manufactured by Chattanooga Group.
[964859]
A female patient, received a 2nd degree burn, on the back during a heat therapy treatment. The patient was treated for 20-25 minutes. The hot pac was applied to the patient's back. During the treatment the clinician observed and inquired with the patient in regards to comfort. The patient expressed no discomfort. Later that evening the patient expressed discomfort in the area of the treatment. The resident nurse examined the area and noted a small blister in the area of treatment. The patient's physician prescribed pain medication and ointment. Later in the evening the patient was still in pain. The patient called 911 and was taken to the emergency room where she was treated. The emergency room physician prescribed the same medical measures as her primary care physician.
Patient Sequence No: 1, Text Type: D, B5
[8195063]
The customer did not return the device for evaluation. Since the device was not returned for evaluation no root cause can be determined. Additional information will be provided via the form 3500a, if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00278 |
| MDR Report Key | 1175950 |
| Report Source | 05 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-08-13 |
| Date of Event | 2008-08-13 |
| Date Mfgr Received | 2008-08-13 |
| Date Added to Maude | 2008-10-02 |
| 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 | M-2 HYDROCOLLATOR |
| Product Code | IRQ |
| Date Received | 2008-09-23 |
| Model Number | 2402 |
| Catalog Number | 2402 |
| 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 | 1210694 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-23 |