MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-22 for READYBATH SHAMPOO CAP * manufactured by Medline Industries, Inc..
[19144948]
One of the nurses noted that the instructions on the readybath shampoo cap indicate the cap can be heated in the microwave for no more than 30 seconds, but does not indicate at what temperature. The instructions caution that heating time may vary according to wattage. The company asked for additional guidance from the local representative, and was given two options: 1) heat in an 800 watt microwave for no more than 30 seconds, or 2) heat in the microwave warmers provided by medline. The company will suggest including the recommended wattage in the instructions to give users some sort of guideline as to duration of heating based on the strength of their microwave if they are not using the manufacturer's warmer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 541922 |
| MDR Report Key | 541922 |
| Date Received | 2004-07-22 |
| Date of Report | 2004-07-22 |
| Date of Event | 2004-07-17 |
| Report Date | 2004-07-22 |
| Date Reported to FDA | 2004-07-22 |
| Date Added to Maude | 2004-09-07 |
| 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 | 3 |
| 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 | READYBATH SHAMPOO CAP |
| Generic Name | DISPOSABLE SHAMPOO CAP |
| Product Code | FYF |
| Date Received | 2004-07-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 531265 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-22 |