MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-11-21 for INSTANT COLD PACK 10104 manufactured by Allegiance Healthcare Corporation.
[15483836]
The pack ruptured as they were activating it and the solution got into the eyes and skin of the clinician. Spoke with staff who stated the employee immediately washed the product contents off of the skin and rinsed the eyes. Employee experienced blurred vision, burning sensation and watering of eyes. Employee went to a physician, who prescribed eye drops. Employee is doing well at this time and has experienced no further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00277 |
| MDR Report Key | 361937 |
| Report Source | 06 |
| Date Received | 2001-11-21 |
| Date of Report | 2001-11-21 |
| Date Mfgr Received | 2001-10-25 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2001-11-29 |
| 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 |
| 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 | 8475784148 |
| 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 | 2001-11-21 |
| Model Number | 10104 |
| Catalog Number | 10104 |
| Lot Number | V1J045 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 351095 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORPORATION |
| Manufacturer Address | 1430 WAUKEGAN ROAD 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 | 2001-11-21 |