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 2019-01-09 for ROTOPRONE 209800-R manufactured by Arjohuntleigh, Inc..
[132489310]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[132489311]
Arjo was notified about patient sustaining deep tissue injuries to both cheeks while using rotoprone bed. The bilateral injuries were first noticed on (b)(6) 2018 and described as maroon in color at the time, but progressed to some blistering and open skin. A wound care nurse also noted very edematous face and tight ett tape around cheeks. Patient has been treated daily with mepilex dressing to face to help with wounds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00003 |
| MDR Report Key | 8230461 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-09 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2018-12-12 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJOHUNTLEIGH, INC. |
| Manufacturer Street | 4958 STOUT DRIVE |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78219 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTOPRONE |
| Generic Name | BED, PATIENT ROTATION, POWERED |
| Product Code | IKZ |
| Date Received | 2019-01-09 |
| Model Number | 209800-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, INC. |
| Manufacturer Address | 4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-09 |