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 2018-04-19 for FREEDOM BATH AF24104US00 manufactured by Arjo Hospital Equipment Ab.
[106621528]
(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 conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[106621529]
Arjohuntleigh was notified that during service of the bathtub performed at the customer facility by arjohuntleigh representative it was identified that device is not secured with the floor attachments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00097 |
| MDR Report Key | 7442464 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-19 |
| Date of Report | 2018-05-17 |
| Date Facility Aware | 2018-03-21 |
| Report Date | 2018-05-17 |
| Date Reported to FDA | 2018-05-17 |
| Date Reported to Mfgr | 2018-05-17 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-04-19 |
| 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 | FREEDOM BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-04-19 |
| Model Number | AF24104US00 |
| Device Availability | Y |
| Device Age | 8 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 | 2018-04-19 |