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 |