MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-02 for PHILIPS manufactured by Philips.
[4326717]
Blisters to back and posterior right thigh in honeycomb pattern noted immediately after removal of innercool pads used for hypothermia protocol. Dates of use: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035473 |
| MDR Report Key | 3731814 |
| Date Received | 2014-04-02 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-02-22 |
| Date Added to Maude | 2014-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | PAD |
| Product Code | FOH |
| Date Received | 2014-04-02 |
| Lot Number | 081-CB-00036 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-02 |