MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-12-03 for SYSTEM ROMEDIC HIGHBACK SLING DISPOSABLE 40892007 manufactured by Handicare Ab.
[3967810]
A pt was being transferred from a chair to a bed using a ceiling lift and a disposable highback lifting sling. As the care givers lifted the pt, the sling tore along the side seam while approx 6 to 8 inches off the chair. The pt fell through the sling, landing back into the chair. No injuries were reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005536958-2013-00046 |
| MDR Report Key | 3521390 |
| Report Source | 99 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-12-03 |
| Date of Event | 2013-11-11 |
| Date Facility Aware | 2013-11-15 |
| Report Date | 2013-12-03 |
| Date Reported to FDA | 2013-12-03 |
| Date Reported to Mfgr | 2013-11-15 |
| Date Added to Maude | 2013-12-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Manufacturer Street | 344 NORTH READING RD. |
| Manufacturer City | EPHRATA PA 17522 |
| Manufacturer Country | US |
| Manufacturer Postal | 17522 |
| Manufacturer G1 | RISE LIFTS, INC. |
| Manufacturer Street | 344 NORTH READING RD. |
| Manufacturer City | EPHRATA PA 17522 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17522 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM ROMEDIC HIGHBACK SLING DISPOSABLE |
| Generic Name | LIFTING SLING |
| Product Code | FMR |
| Date Received | 2013-12-03 |
| Catalog Number | 40892007 |
| ID Number | LARGE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | BOX 640 JARFALLA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-03 |