MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for BREG POLAR CARE CUBE 10701 manufactured by Breg, Inc..
[82145373]
Patient Sequence No: 1, Text Type: N, H10
[82145374]
Patient cold therapies post-ortho surgery; using cold packs which leaked. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6776818 |
| MDR Report Key | 6776818 |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-05-01 |
| Report Date | 2017-08-02 |
| Date Reported to FDA | 2017-08-02 |
| Date Reported to Mfgr | 2017-08-02 |
| Date Added to Maude | 2017-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | BREG |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | IME |
| Date Received | 2017-08-09 |
| Model Number | POLAR CARE CUBE |
| Catalog Number | 10701 |
| Lot Number | 272130207 |
| ID Number | L3 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREG, INC. |
| Manufacturer Address | 2885 LOKER AVENUE E CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-09 |