MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-09-10 for UNKNOWN COLD PACK UNKCOLDPK manufactured by Cardinal Health.
[16717064]
Reporter said that it was a very old gel pack which she borrowed from a friend. She said, she took it out of the freezer and applied it directly to her back, instead of wrapping it like the instructions say, but she said she has never wrapped packs before applying them to her skin and has not had a problem. She said it wasn't "super cold" and that it felt okay when she put it on, but later in the night it somehow punctured and leaked onto her skin, which she noticed because of the blue on her clothing. She changed her clothes, but did not was her skin. When she woke up, she said that her back was red, hot to touch, and burning. She said, she thought it was more like a chemical burn than a freezer burn. She said she went to her doctor, and her doctor wasn't sure what it was, and thought it might be the shingles. She said that people she had talked to said it looked more like a chemical burn to her. She said the main thing she is worried about is what chemical was touching her skin, and she wants to know what her chemical exposure is.
Patient Sequence No: 1, Text Type: D, B5
[16974858]
Unfortunately, no lot number was provided so the dhr (device history record) could not be reviewed. The product sample reportedly was available but was not received from the customer. Consequently, we were unable to determine the root cause of the problem reported. Under routine 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. It is vital to the investigation that the product sample be available for examination and testing in order to determine the root cause. Unfortunately, no samples were provided, so the exact cause of the difficulties encountered cannot be confirmed. In addition, the complainant states that she did not follow the instructions as stated on the pack for either the duration of therapy or for the direct placement on skin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2008-00071 |
| MDR Report Key | 1156748 |
| Report Source | 04 |
| Date Received | 2008-09-10 |
| Date of Report | 2008-09-08 |
| Date of Event | 2008-08-17 |
| Date Mfgr Received | 2008-08-19 |
| Date Added to Maude | 2009-06-03 |
| 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 | 0 |
| 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 City | MOBERLY MO |
| Manufacturer Country | US |
| Single Use | 0 |
| 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 | 2008-09-10 |
| Model Number | UNKCOLDPK |
| Catalog Number | UNKCOLDPK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-10 |