MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for SLINGS, CLIP MAA4031-M manufactured by Arjohuntleigh Polska Sp Z O.o.
[130049383]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[130049384]
It was reported that during initial phase of transfer clips of the toilet sling (model number: maa4031m-m) let loose and detached from the 3rd party lift. There was no injury or fall reported. Patient was still sitting on the wheelchair when the incident occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00226 |
| MDR Report Key | 8150292 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-10 |
| Date Facility Aware | 2018-11-13 |
| Report Date | 2018-12-20 |
| Date Reported to FDA | 2018-12-20 |
| Date Reported to Mfgr | 2018-12-20 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62052 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, |
| Manufacturer Country | PL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SLINGS, CLIP |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2018-12-11 |
| Model Number | MAA4031-M |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, PL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-11 |