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 2019-04-30 for ROTOPRONE 209500 manufactured by Arjohuntleigh, Inc..
[143606201]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[143606202]
On 4 april 2019 arjo was informed that a patient sustained several pressure injuries (from stage 2 to deep tissue injuries) during therapy on the rotoprone system. The patient was admitted on (b)(6) 2019. The patient was on the rotoprone bed since (b)(6). Pressure injuries (located on right cheek, right chest, right plantar foot, right buttocks, left knee, left posterior shoulder, left plantar foot/left 4th toe, lower back) were noticed between (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00042 |
| MDR Report Key | 8566374 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-30 |
| Date of Report | 2019-05-28 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-04-30 |
| 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 | 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 | 2019-04-30 |
| 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 | 2019-04-30 |