MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for STANDARD COLD PACK MDS137000 manufactured by Medline Industries, Inc..
[183517162]
Opened a cold pack and contents poured out onto the floor. Manufacturer response for cold pack, standard cold pack (per site reporter). Manufacturer assumed staff not following directions on how to open. A video from manufacturer along with an sbar was sent out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9834982 |
| MDR Report Key | 9834982 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-02 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STANDARD COLD PACK |
| Generic Name | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | IMD |
| Date Received | 2020-03-16 |
| Catalog Number | MDS137000 |
| Lot Number | RA19310CAN1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |