MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-04-27 for PARKER BATH AL27010-EU manufactured by Arjohuntleigh Polska Sp Z O.o.
[106701534]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[106701535]
Arjohuntleigh was notified about an event with involvement of parker bath, where it was reported that the caregiver wanted to open the bath door, but it seemed stuck. Only when using quite some force the caregiver was able to open it, but also sustained a shoulder injury. No patient involvement was reported. As a result the caregiver have not full mobility of her arm and can only work part time. Up to present day, the caregiver did not regain full arm mobility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00101 |
| MDR Report Key | 7467764 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-27 |
| Date of Report | 2018-05-18 |
| Date of Event | 2017-12-01 |
| Date Facility Aware | 2018-04-09 |
| Report Date | 2018-05-18 |
| Date Reported to FDA | 2018-05-18 |
| Date Reported to Mfgr | 2018-05-18 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2015-10-29 |
| Date Added to Maude | 2018-04-27 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-04-27 |
| Model Number | AL27010-EU |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 2 YR |
| 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, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-04-27 |