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 C-5 120V 3102 manufactured by Chattanooga Group.
[964555]
A male pt was receiving cold therapy for an acl repair of the knee when the pt rec'd a cold burn to the skin surface. The clinician had noted prior to the cold treatment application that the pac was abnormally hard. The clinician applied the cold pac to the injury area. The pt completed the 20 minute without complaint. Upon removal of the treatment pac, the clinician noted redness of the skin in the area treatment. The pt did not require medical attention as a result of the redness. The pt contacted the clinic three days later to report that the skin discoloration had cleared up.
Patient Sequence No: 1, Text Type: D, B5
[8100953]
The device evaluation and any additional findings will be provided upon conclusion of the device eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00257 |
| MDR Report Key | 1171154 |
| Report Source | 05 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-07-08 |
| Date of Event | 2008-07-08 |
| Date Mfgr Received | 2008-07-08 |
| Date Added to Maude | 2008-09-29 |
| 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 | C-5 120V |
| Product Code | IMF |
| Date Received | 2008-09-23 |
| Returned To Mfg | 2008-07-22 |
| Model Number | 3102 |
| Catalog Number | 3102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1203846 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-23 |