MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-25 for HANDSET FOR OSCAR II OH300 manufactured by Orthofix Srl.
[141227272]
Technical evaluation: the device involved has not been received yet by orthofix (b)(4). The technical evaluation will be performed as soon as device becomes available. Medical evaluation: the little information made available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the investigation are available. Orthofix (b)(4) has requested further information on the event, such as code and batch number of the device involved; patient diagnosis; surgery description; body part to which device was applied; patient information (age, sex, weight and height); information on patient adverse effects, if any; copies of the operative report and copies of the pre and post-operative x-rays; information on patient current health condition and device availability for the technical evaluation. As of today, orthofix (b)(4) did not receive any further details on the event. As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141227273]
The information provided by the local distributor indicates: title: (b)(4) - handset fault - s/n (b)(4). Description: handset overheated and burnt surgeon and nurse. I do not have any details on the serial number, or any further details of the fault at this stage. No other information was given. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00009 |
| MDR Report Key | 8366493 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-02-25 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-05-06 |
| Date Added to Maude | 2019-02-25 |
| 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 | MR. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDSET FOR OSCAR II |
| Generic Name | HANDSET FOR OSCAR II |
| Product Code | JDX |
| Date Received | 2019-02-25 |
| Returned To Mfg | 2019-03-01 |
| Model Number | OH300 |
| Catalog Number | OH300 |
| Lot Number | 2H2952 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, ITALY 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-25 |