MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for TORTOISE POSITIONING SYSTEM SUN TORT100 manufactured by Molnlycke Healthcare.
[55568531]
A facility reported that a patient was being repositioned by a pca, not an rn. When the pca pulled on the handles of the positioner, the patient rolled out of bed, over the guard rail, fell to the floor and broke their shoulder. Multiple requests have been made to obtain additional information, however no further details have been provided at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004763499-2016-00007 |
| MDR Report Key | 5974221 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-11 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-09-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMIE BRADSHAW |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4703750051 |
| Manufacturer G1 | MOLNLYCKE HEALTHCARE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TORTOISE POSITIONING SYSTEM |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2016-09-23 |
| Model Number | SUN TORT100 |
| Operator | NURSING ASSISTANT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTHCARE |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-23 |