MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-11-07 for RETURN 7500 manufactured by Handicare Ab.
[128259729]
Wing handles near device base plate detach from device during patient transfer from wheelchair to chair. The patient did not sustain any injury from the event. The device was operated by lay user in the patient's home. The device was quarantined after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009481053-2018-00045 |
| MDR Report Key | 8048094 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-11-07 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-09-29 |
| Date Mfgr Received | 2018-10-12 |
| Date Added to Maude | 2018-11-07 |
| 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. YI-QIN BU |
| Manufacturer Street | SWEDEN TORSHAMNSGATAN 35 |
| Manufacturer City | KISTA, |
| Manufacturer G1 | BRAKO D.O.O |
| Manufacturer Street | RASHTANSKI PAT 2 |
| Manufacturer City | VELES, VELES 1400 |
| Manufacturer Country | MK |
| Manufacturer Postal Code | 1400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETURN |
| Generic Name | TRANSFER AID |
| Product Code | IKX |
| Date Received | 2018-11-07 |
| Model Number | 7500 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | SWEDEN TORSHAMNSGATAN 35 KISTA, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-07 |