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 2020-02-10 for ROTOPRONE 209800 manufactured by Arjohuntleigh, Inc..
[188581340]
Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4). Currently, this product is to be handled by (b)(4) ab? S complaint handling establishment and any medwatch reports will be submitted under registration (b)(4). Additional information will be provided once the investigation conclusions are available.
Patient Sequence No: 1, Text Type: N, H10
[188581341]
Patient had developed bilateral deep tissue on forehead and cheeks. Injuries developed within 12-18 hours while the patient was in prone position. There was no product failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2020-00011 |
| MDR Report Key | 9687047 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-10 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 688282467 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG J1X5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X5Y5 |
| 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 | 2020-02-10 |
| Model Number | 209800 |
| 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. Other | 2020-02-10 |