MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for INSTANT ICE COMPRESS 172464 manufactured by Hcs, Dyad Medical Sourcing, Llc.
[117977716]
During activation of the product, it was noted to have a leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7808399 |
| MDR Report Key | 7808399 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-08-17 |
| Report Date | 2018-08-20 |
| Date Reported to FDA | 2018-08-20 |
| Date Reported to Mfgr | 2018-08-23 |
| Date Added to Maude | 2018-08-23 |
| 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 | INSTANT ICE COMPRESS |
| Generic Name | COLD PACK |
| Product Code | IME |
| Date Received | 2018-08-23 |
| Model Number | NA |
| Catalog Number | 172464 |
| Lot Number | 180104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HCS, DYAD MEDICAL SOURCING, LLC |
| Manufacturer Address | 2101 WAUKEGAN RD STE 208 BANNOCKBURN IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-23 |