MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for ACCU-THERM INSTANT COLD PACK manufactured by Medline Industries, Inc..
[182983353]
Patient developed redness and blistering on hip after use. This item was a sub for another (other brands) product. The staff reported that this item was colder initially and stayed much colder for longer than other brand's products. Staff reported that after 5 min of use on themselves as a test that the coldness became "uncomfortable".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9818437 |
| MDR Report Key | 9818437 |
| Date Received | 2020-03-11 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-07-23 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| 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 | ACCU-THERM INSTANT COLD PACK |
| Generic Name | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | IMD |
| Date Received | 2020-03-11 |
| Lot Number | 400709 |
| Device Availability | * |
| 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 | 1. Other | 2020-03-11 |