MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2005-12-05 for UNKNOWN COLD PACK UNKCOLDPK manufactured by Cardinal Health.
[17024855]
According to info forwarded by cardinal legal dept. , in 2003, while at her place of employment pt felt a muscle pull in her upper back. Pt received from her workplace a jack frost ice pack which she "wrapped in a towel and placed on the injured area of her back. Within two or three minutes, pt felt a burning sensation on her back where she had placed the ice pack. She immediately removed the ice pack. Pt sustained a partial thickness burn on her back on the area where she had placed the ice pack. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00141 |
| MDR Report Key | 649258 |
| Report Source | 00,04 |
| Date Received | 2005-12-05 |
| Date of Report | 2005-12-05 |
| Date of Event | 2003-10-07 |
| Date Mfgr Received | 2005-11-08 |
| Date Added to Maude | 2005-12-06 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONALICH |
| 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 | UNKNWON COLD PACK |
| Product Code | KYR |
| Date Received | 2005-12-05 |
| Model Number | UNKCOLDPK |
| Catalog Number | UNKCOLDPK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 638751 |
| 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 | 2005-12-05 |