MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2001-06-13 for INSTANT COLD PACK 10104 manufactured by Allegiance Healthcare Corp.
[21696701]
Employee sustained injury, used ice pack & took ice pack home. The employee then refroze and applied to right calf after sustaining another injury. The pack fell down to ankle area and the employee sustained 3" x 4" maroon discoloration to skin. The employer recommended the employee seek medical attention regarding matter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00169 |
| MDR Report Key | 336894 |
| Report Source | 00,06 |
| Date Received | 2001-06-13 |
| Date of Report | 2001-06-13 |
| Date Mfgr Received | 2001-05-14 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2001-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTANT COLD PACK |
| Generic Name | COLD PACK |
| Product Code | IMF |
| Date Received | 2001-06-13 |
| Model Number | 10104 |
| Catalog Number | 10104 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 326198 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Baseline Brand Name | INSTANT COLD PACK |
| Baseline Generic Name | COLD PACK |
| Baseline Model No | 10104 |
| Baseline Catalog No | 10104 |
| Baseline ID | NA |
| Baseline Device Family | COLD PACK |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-13 |