MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for SMITH AND NEPHEW SPIDER BEACH CHAIR POSITIONER PRODUCT # 7210552 manufactured by Smith And Nephew, Inc..
[181721028]
Surgical tech was preparing to box a piece of equipment on loan from the mfr. She lifted the equipment and it slipped a little. Her arm was caught in the hydraulics which tightened around her arm. When she tried to remove her arm. It tightened around it more. Staff came to assist. The employee was getting very upset so they had her sit down on the floor so she did not fall and make the situation worse. Two surgeons were able to talk her into moving her arm over and then she was able to remove from the equipment. The employee's arm was examined by the surgeon who had used the equipment. He did not see any injury. The employee declined further med evaluation. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093339 |
| MDR Report Key | 9763930 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITH AND NEPHEW SPIDER BEACH CHAIR POSITIONER |
| Generic Name | SUPPORT, PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-24 |
| Model Number | PRODUCT # 7210552 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH AND NEPHEW, INC. |
| Manufacturer Address | ANDOVER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |