MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-06-17 for INSTANT COLD PACK 10104 manufactured by Cardinal Health.
[306014]
Account states that the ice pack was giving to patient from dr. Office patient received a pain injection in the back. It is stated that when patient woke up the next day patient had huge blisters and a fever. Patient went to the emergency room and was given antibiotics. The blisters popped the next day and were worse, bleeding. On second day the patient returned to the emergency room with pain and received no treatment. Patient went to the physician and he said that patient may have had the ice pack on the back too long. Patient missed work for 2 weeks. When asked how long patient had the ice pack on the back, spouse stated that patient used it in the evening, not all night. The physician took pictures of the area and performed tests. The sample is available. A kit needs to be sent to their home for returning the sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00081 |
| MDR Report Key | 466943 |
| Report Source | 04 |
| Date Received | 2003-06-17 |
| Date of Report | 2003-06-17 |
| Date of Event | 2003-04-30 |
| Date Mfgr Received | 2003-05-23 |
| Date Added to Maude | 2003-06-23 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PARTICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| 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 | 2003-06-17 |
| Model Number | 10104 |
| Catalog Number | 10104 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 455888 |
| Manufacturer | CARDINAL HEALTH |
| 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 | 2003-06-17 |