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 2018-04-17 for MAXISLIDE SHEET NSA0500-US manufactured by Arjohuntleigh Polska Sp. Z O.o..
[106271573]
(b)(4). Additional information will be provided upon conclusions of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[106271574]
On (b)(6) 2018 arjo has become aware of an event that occurred at one of the facilities placed in colorado, usa. It was reported that a facility employee (manager) slipped on the floor, as he/she sat on a sliding sheet placed on a chair. As a result, the employee sustained an injury. No more information has been released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00090 |
| MDR Report Key | 7435505 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-17 |
| Date of Report | 2018-05-28 |
| Date of Event | 2018-03-10 |
| Date Facility Aware | 2018-03-19 |
| Report Date | 2018-05-28 |
| Date Reported to FDA | 2018-05-28 |
| Date Reported to Mfgr | 2018-05-28 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-04-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXISLIDE SHEET |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2018-04-17 |
| Model Number | NSA0500-US |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-17 |