MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2000-12-13 for MAXISLIDE NSAXXXX NSA0500-GB manufactured by Arjo, Ltd..
[17807641]
The facility reports while the pt was under anesthesia, the operating table was positioned in the head-down position. In this position, the pt slid down the table and was prevented from falling off the operating table by the anesthesiologist's equipment and physical restraint by members of the staff. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617021-2000-00222 |
| MDR Report Key | 308637 |
| Report Source | 01,06 |
| Date Received | 2000-12-13 |
| Date of Report | 2000-12-13 |
| Date of Event | 2000-11-13 |
| Date Mfgr Received | 2000-11-13 |
| Date Added to Maude | 2000-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | TRACI GIOVENCO |
| Manufacturer Street | 50 N. GARY AVE. SUITE A |
| Manufacturer City | ROSELLE IL * |
| Manufacturer Country | US |
| Manufacturer Postal | * |
| Manufacturer Phone | 6303076140 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXISLIDE |
| Generic Name | SLIDING SHEET |
| Product Code | KME |
| Date Received | 2000-12-13 |
| Model Number | NSAXXXX |
| Catalog Number | NSA0500-GB |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 298619 |
| Manufacturer | ARJO, LTD. |
| Manufacturer Address | ST. CATHERINE ST. GLOUCESTER UK GL1 2SL |
| Baseline Brand Name | MAXISLIDE |
| Baseline Generic Name | SLINDING SHEET |
| Baseline Model No | NSAXXXX |
| Baseline Catalog No | NSA0500-GB |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-12-13 |