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 2019-05-08 for ROTOPRONE 209500 manufactured by Arjohuntleigh, Inc..
[144404389]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[144404390]
On 11 apr 2019 arjo was informed about a patient who sustained deep tissue injury while on the rotoprone system. The event occurred in (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00044 |
| MDR Report Key | 8590586 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-08 |
| Date of Report | 2019-06-07 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-05-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2019-05-08 |
| Model Number | 209500 |
| 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. Hospitalization | 2019-05-08 |