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 2018-05-28 for MALIBU/SOVEREIGN AZL23110-GB manufactured by Arjo Hospital Equipment Ab.
[109362056]
(b)(4). (b)(4). Additional information will be provided upon the investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[109362057]
Arjo was notified about an incident with involvement of malibu bathtub. According to the available event description the caregiver was using the chair function of the bath to turn the resident. The caregiver turned to empty bath and while this was being done the resident fell off the chair. The resident sustained a laceration to her eyebrow and a black eye. The resident was taken to hospital. Two paper stitches were applied to head wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00115 |
| MDR Report Key | 7547589 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-28 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-05-07 |
| Date Facility Aware | 2018-05-14 |
| Report Date | 2018-06-20 |
| Date Reported to FDA | 2018-06-20 |
| Date Reported to Mfgr | 2018-06-20 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2009-11-13 |
| Date Added to Maude | 2018-05-28 |
| 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 | MALIBU/SOVEREIGN |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-05-28 |
| Model Number | AZL23110-GB |
| Operator | OTHER CAREGIVERS |
| 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. Hospitalization; 2. Other | 2018-05-28 |