MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-12 for COMFORT RINSE-FREE SHAMPOO CAP 7909 UNK manufactured by Sage Products Inc..
[2162848]
Unresponsive, ventilated patient sustained a second degree burn to forehead and nape of neck following use of no-rinse shower cap. Rn heated product according to manufacturer's and product package instructions. Burn noted after cap was removed after approximately five minutes. Physician made aware and ordered silvadene to affected areas and consulted wound care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2263438 |
| MDR Report Key | 2263438 |
| Date Received | 2011-09-12 |
| Date of Report | 2011-09-12 |
| Date of Event | 2011-09-11 |
| Report Date | 2011-09-12 |
| Date Reported to FDA | 2011-09-12 |
| Date Added to Maude | 2011-09-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT RINSE-FREE SHAMPOO CAP |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2011-09-12 |
| Model Number | 7909 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS INC. |
| Manufacturer Address | 3909 THREE OAKS RD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-12 |