MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-10-12 for FLUIDAIR ELITE manufactured by Arjohuntleigh, Inc..
[123490215]
Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4). From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #(b)(4). From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[123490216]
On (b)(6) 2018 arjo was notified about a lawsuit involving an arjo fluidair elite bed. It was stated that in 2014/2015 during in-patient stay in the va hospital, a patient developed pressure wounds on both of his calves that resulted in his right leg amputation. His left leg was saved. It was stated that during at least part of this time, he was in an arjo fluidair elite bed. There was no allegations that arjo fluidair elite bed malfunctioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00198 |
| MDR Report Key | 7959438 |
| Report Source | OTHER |
| Date Received | 2018-10-12 |
| Date of Report | 2018-11-19 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-10-12 |
| 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 | FLUIDAIR ELITE |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-10-12 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2018-10-12 |