MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-11-22 for PACK COLD INSTANT MEDIUM 10104 manufactured by Cardinal Health.
[312909]
Family member called and stated that pt used the 10104 instant cold pack in 10/2004 for approx 30 minutes and received what the pt refers to as 2nd or 3rd degree burns, as if they had put their hands on a hot store. Area is now red and blistered. Pictures attached to the complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00122 |
| MDR Report Key | 556084 |
| Report Source | 04 |
| Date Received | 2004-11-22 |
| Date of Report | 2004-11-22 |
| Date Mfgr Received | 2004-10-24 |
| Date Added to Maude | 2004-11-24 |
| 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 KM |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACK COLD INSTANT MEDIUM |
| Generic Name | INSTANT COLD PACK |
| Product Code | IMF |
| Date Received | 2004-11-22 |
| Model Number | 10104 |
| Catalog Number | 10104 |
| 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 | 545753 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * 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. Required No Informationntervention | 2004-11-22 |