MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-31 for INSTANT ICE COMPRESS UN HCS1100 manufactured by Dyad Medical Sourcing, Llc.
[35185701]
When nurse activated an instant ice compress, it busted in her face. Small tear to back bottom right corner noted afterwards. Evaluated in ed-dx chemical conjunctivitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058945 |
| MDR Report Key | 5348118 |
| Date Received | 2015-12-31 |
| Date of Report | 2015-10-31 |
| Date of Event | 2015-08-04 |
| Date Added to Maude | 2016-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | INSTANT ICE COMPRESS |
| Generic Name | ICE PACK |
| Product Code | KYR |
| Date Received | 2015-12-31 |
| Model Number | UN |
| Catalog Number | HCS1100 |
| Lot Number | 150803 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYAD MEDICAL SOURCING, LLC |
| Manufacturer Address | 2101 WAUKEGAN ROAD STE 208 BANNOCKBURN IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-31 |