MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for BREG POLAR CARE CUBE 10701 manufactured by Breg, Inc..
[141478763]
Our hospital has noticed a trend in ice/water containers leaking during post-surgical orthopedic surgery. No harm to any patients but over the past month or so we've see approximately 9 ice coolers and/ or their connected pads leaking. We have been sending the ice boxes and pads back to the manufacturer for replacements and we came to understand the consistent need to replace so many we felt it time to look at the issue. Most ice cooler boxes and the related connecting pads are not fully identified as far as lot numbers; however, we felt we needed to move forward with at least 1 lot number of a known-device. Again, no patient harm but just aspect of the devices consistently leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499835 |
| MDR Report Key | 8499835 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-02-08 |
| Report Date | 2019-02-21 |
| Date Reported to FDA | 2019-02-21 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | ILO |
| Date Received | 2019-04-10 |
| Returned To Mfg | 2019-02-20 |
| Model Number | POLAR CARE CUBE |
| Catalog Number | 10701 |
| Lot Number | 292368283 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREG, INC. |
| Manufacturer Address | 2885 LOKER AVENUE EAST CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |