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 2019-03-14 for SKIN IQ 365 SIQCPRUS1UN manufactured by Getinge Dominican Republic Sa.
[138813767]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[138813768]
Arjo was informed that a customer staff sustained back injury while repositioning patient in the bed. It was reported that the patient was a quadriplegic with a progressive disease, and continually sliding down in bed. According to a nurse, the patient was sliding down because of the slippery sheet that went with the mattress and the nature of the mattress itself. The customer could not identify the products involved in the event, but upon arjo investigation, we concluded that most likely arjo skin iq 365 (described as sheet by the nurse) was used with non-arjo mattress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012292104-2019-00006 |
| MDR Report Key | 8420725 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-14 |
| Date of Report | 2019-06-17 |
| Date of Event | 2018-11-30 |
| Date Facility Aware | 2019-02-13 |
| Report Date | 2019-06-17 |
| Date Reported to FDA | 2019-06-17 |
| Date Reported to Mfgr | 2019-06-17 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-14 |
| 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 | GETINGE DOMINICAN REPUBLIC SA |
| Manufacturer Street | PARQUE INDUSTRIAL ITABO (PIISA) BLDG 9 |
| Manufacturer City | HAINA, SAN CRIST?BAL, 10903 |
| Manufacturer Country | DR |
| Manufacturer Postal Code | 10903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN IQ 365 |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2019-03-14 |
| Model Number | SIQCPRUS1UN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DOMINICAN REPUBLIC SA |
| Manufacturer Address | PARQUE INDUSTRIAL ITABO (PIISA) BLDG 9 HAINA, SAN CRIST?BAL, 10903 DR 10903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-14 |