MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for DONJOY ICEMAN CLASSIC 1100 manufactured by Djo, Llc.
[35011604]
Patient Sequence No: 1, Text Type: N, H10
[35011665]
The pt was given a donjoy cryo-cuff and cooler for postoperative care following surgery. At follow up appointment, the pt reported that cryo-cuff cooler was not pumping iced water, and that motor was hot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5343070 |
| MDR Report Key | 5343070 |
| Date Received | 2016-01-05 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-11-06 |
| Report Date | 2015-11-12 |
| Date Reported to FDA | 2015-11-12 |
| Date Reported to Mfgr | 2015-11-12 |
| Date Added to Maude | 2016-01-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY ICEMAN CLASSIC |
| Generic Name | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2016-01-05 |
| Model Number | 1100 |
| Lot Number | 092215-01M |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET, VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |