MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-03-02 for UNKNOWN COLD PACK UNKCOLDPK manufactured by Cardinal Health.
[402959]
Caller said her son was kicked at school and he went to the nurse's office saying it was hurting. She said the nurse took the cold pack out of teh freezer, applied it to the injured area, and told her sone to leave it on about 20 minutes, then go back to class. She said that evening there was a red rectangular area on the leg that was really red, and tiny water blisters were forming. She said by late saturday afternoon it was "oozing" out of the blisters, so they took him to the er. At er they were told it was infected and they gave her son antibiotics to take. She said it is looking better, but she thinks it is going to leave a scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2006-00024 |
| MDR Report Key | 681401 |
| Report Source | 04 |
| Date Received | 2006-03-02 |
| Date of Report | 2006-03-02 |
| Date of Event | 2006-01-27 |
| Date Mfgr Received | 2006-01-31 |
| Date Added to Maude | 2006-03-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | MOBERLY MO * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN COLD PACK |
| Generic Name | UNKNOWN COLD PACK |
| Product Code | KYR |
| Date Received | 2006-03-02 |
| Model Number | UNKCOLDPK |
| Catalog Number | UNKCOLDPK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 670668 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | UNK COLD PACK |
| Baseline Generic Name | COLD PACK |
| Baseline Model No | UNKCOLDPK |
| Baseline Catalog No | UNKCOLDPK |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-02 |