MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-16 for MATTRESS SHEETS (DISPOSABLE), 46' X 84" manufactured by Global Healthcare.
[1800656]
Pt came to the emergency room. Placed on a crib with a disposable fitted sheet. Pt was laying on her right side and presents a 1st degree burn. Skin biopsy was required. Dates of use: (b)(6), 2009. Event abated after use: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018248 |
| MDR Report Key | 1905768 |
| Date Received | 2010-11-16 |
| Date of Event | 2010-10-14 |
| Date Added to Maude | 2010-12-07 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | MATTRESS SHEETS (DISPOSABLE), 46' X 84" |
| Product Code | KME |
| Date Received | 2010-11-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBAL HEALTHCARE |
| Manufacturer Address | GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-11-16 |