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 2017-08-16 for PARKER BATH manufactured by Arjo Hospital Equipment Ab.
[82753166]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[82753167]
On (b)(6) 2017 arjohuntleigh has been initially notified about an incident that involves parker bath. It was indicated that while drying the patient the tub door came down and hit the caregiver on the head. As a result of the incident the caregiver suffered a concussion and whiplash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00174 |
| MDR Report Key | 6796591 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-08-16 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-08-07 |
| Date Facility Aware | 2017-08-14 |
| Report Date | 2017-09-27 |
| Date Reported to FDA | 2017-09-27 |
| Date Reported to Mfgr | 2017-09-27 |
| Date Mfgr Received | 2017-08-14 |
| Device Manufacturer Date | 2007-10-08 |
| Date Added to Maude | 2017-08-16 |
| 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 | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal | 24121 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2017-08-16 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 10 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. Hospitalization | 2017-08-16 |