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 2018-05-16 for PARKER BATH AL21000-GB manufactured by Arjohuntleigh Polska Sp. Z O.o..
[129312935]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration #(b)(4)). As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[129312936]
It was reported that caregiver was bathing the patient, when the door opened and the water flooded out. The caregiver caught the patient to stop her falling out of the bath. The patient did not sustain injury. The caregiver jarred her shoulder, when catching the patient. The caregiver taken pain killers. No malfunction of the bath was detected. According to the collected information the door was not locked fully and opened while the caregiver was on the other side of the bath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00225 |
| MDR Report Key | 7517579 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-16 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-11-08 |
| Date Facility Aware | 2018-11-08 |
| Report Date | 2018-12-18 |
| Date Reported to FDA | 2018-12-18 |
| Date Reported to Mfgr | 2018-12-18 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2018-05-16 |
| 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 | 0 |
| Brand Name | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-05-16 |
| Model Number | AL21000-GB |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2018-05-16 |