MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-08-30 for UNKNOWN COLD PACK UNKCOLDPK UNCOLDPK manufactured by Cardinal Health.
[18140214]
She said, she had received the gel pack from someone else. She said, the pack was frozen, and she placed it in a towel and then placed it on her back and lay down. She said, that is was on her back for less than 10 minutes and she noticed it was really cold, so she took it off her back. That is when she said that she noticed a burn on her back. She went to the doctor, and said that by this time, there was blister forming and the burned area was 5 1/2"x6: in diameter.
Patient Sequence No: 1, Text Type: D, B5
[18359031]
As no samples were provided to date, the exact cause of the difficulties encountered cannot be determined. In addition, no lot number was reported, so the device history record could not be reviewed. Under routing production, a sampling of these units is tested for pouch integrity and the production run is not released until all aspects of product quality meet product specifications. Although great effort is taken in ensuring that all function as designed, at times, one may fail to meet performance expectations for a certain reason. In those instances, it is vital to the investigation that the product sample be available for examination and testing in order to determine the root cause. Unfortunately, in this situation that is not the case. We will continue to monitor for other similar complaints and utilize the information as part of continuous improvement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2006-00100 |
| MDR Report Key | 756492 |
| Report Source | 04 |
| Date Received | 2006-08-30 |
| Date of Report | 2006-08-30 |
| Date of Event | 2006-06-14 |
| Date Mfgr Received | 2006-07-31 |
| Date Added to Maude | 2006-09-05 |
| 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 | MCRAW 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 | 2006-08-30 |
| Model Number | UNKCOLDPK |
| Catalog Number | UNCOLDPK |
| 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 | 744382 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-30 |