MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-05 for PARKER BATH AL11000-GB manufactured by Arjo Hospital Equipment Ab.
[128199344]
(b)(4). Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[128199345]
It was reported that while caregiver was assisting the patient in the bath, the door fell down and hit the caregiver on the head. According to the received information the caregiver sustained a head injury. No further details regarding outcome and treatment are currently available. Please note that arjo was notified about the event with a delay. Arjo representative will contact the customer facility to obtain more information if available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00209 |
| MDR Report Key | 8036878 |
| Report Source | OTHER |
| Date Received | 2018-11-05 |
| Date of Report | 2018-12-03 |
| Date of Event | 2016-12-05 |
| Date Facility Aware | 2018-10-22 |
| Report Date | 2018-12-03 |
| Date Reported to FDA | 2018-12-03 |
| Date Reported to Mfgr | 2018-12-03 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2007-05-28 |
| Date Added to Maude | 2018-11-05 |
| 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 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| 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 | 2018-11-05 |
| Model Number | AL11000-GB |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-05 |