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 2018-03-19 for PARKER BATH AL11110-US manufactured by Arjo Hospital Equipment Ab.
[103277150]
(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 upon the investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[103277151]
Arjohuntleigh was notified about an event with involvement of parker bath, where it was reported that during use the caregiver pulled down the door to close and door fell on the caregiver's left arm. According to the received information the caregiver's arm was swollen and it was cooled with ice to remove the swelling. The arm also had some slight scratches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00067 |
| MDR Report Key | 7348001 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-19 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-02-16 |
| Date Facility Aware | 2018-02-21 |
| Report Date | 2018-04-17 |
| Date Reported to FDA | 2018-04-17 |
| Date Reported to Mfgr | 2018-04-17 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2006-08-29 |
| Date Added to Maude | 2018-03-19 |
| 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 | 2018-03-19 |
| Model Number | AL11110-US |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-19 |