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 2017-12-28 for SYSTEM 2000 manufactured by Arjohuntleigh Polska Sp Z O.o.
[96119344]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[96119345]
On 2017-dec-21 arjohuntleigh was informed that during the disinfection of system 2000 bathtub the customer facility personal support worker was exposed to the undiluted arjoclean iv disinfectant, which came in contact with her skin (above the glove, in the elbow area). The psw was changing the disinfectant bottle, when some of the disinfectant sprayed out of the bottle as it was placed in the reservoir of the tub. The customer facility personal support worker sustained a skin irritation on right arm. Based on the information provided, the person injured was not objected to any medical intervention and performed a self care of the irritated area. The event occurred approximately 1. 5 years ago (exact date was not available), but was not reported to arjohuntleigh to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00235 |
| MDR Report Key | 7152552 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-12-28 |
| Date of Report | 2018-01-22 |
| Date Facility Aware | 2017-12-21 |
| Report Date | 2018-01-22 |
| Date Reported to FDA | 2018-01-22 |
| Date Reported to Mfgr | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| Date Added to Maude | 2017-12-28 |
| 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 | 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 | SYSTEM 2000 |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2017-12-28 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-28 |