MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-15 for LIFT SHEET INCLUDED IN A CLEAN UP INFECTION CONTROL SYSTEM 10 C10308 manufactured by Microtek Medical, Inc..
[1759455]
Recently we reviewed a surgery case where a patient almost slid off an or table. It was determined the patient was correctly positioned. During the review staff made a comment regarding a contributing factor could have been the lift sheet. They reported the lift sheets were "slippery. " some staff members said they quit using the lift sheets because of this reason. Additionally the lift sheet was not always used because the sheet would stretch or "give" when a patient's weight was placed on it. This type of product was used for approximately one year. From a human factor standpoint staff did not report this earlier as they said they liked the other components included in the multi pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932895 |
| MDR Report Key | 1932895 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-12-15 |
| Date of Event | 2010-12-02 |
| Report Date | 2010-12-15 |
| Date Reported to FDA | 2010-12-15 |
| Date Added to Maude | 2010-12-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | LIFT SHEET INCLUDED IN A CLEAN UP INFECTION CONTROL SYSTEM |
| Generic Name | LIFT SHEET |
| Product Code | KME |
| Date Received | 2010-12-15 |
| Model Number | NA |
| Catalog Number | 10 C10308 |
| Lot Number | C10318 |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL, INC. |
| Manufacturer Address | 602 LEHMBERG RD COLUMBUS MS 39702 US 39702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-15 |