MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for CARIBOU 31860104 manufactured by R82 A/s.
[129452459]
Caribou inspected at (b)(6) and there were found no defects or damage on the product. According to the caribou user guide a user must not be left unattended in the product and supervision of an adult is to be ensured. The user was left in the product without supervision for 15-20 min. Seat returned: the chest strap should have been mounted between shoulder supports and seat. The chest strap is mounted incorrectly by the user, as the chest strap is outside both shoulder supports and side supports mounted. It is still possible to close both velcro and plastic bracket, but the overlap in the strap is much shorter than intended. Conclusion: user mistake - incorrect use of the chest strap combined with leaving the user unattended and without supervision of an adult.
Patient Sequence No: 1, Text Type: N, H10
[129452460]
The patient is standing in the table standing device after returning from the day center. The assistant gives a newspaper to the patient, buses a bit with him and then leaves the room to pick up some small things, dishes and more. After 15-20 minutes the assistant hears something from the patient. He hurries up and find the patient leaning forward. The assistant then finds that the velcro strap and plastic bracket that holds the strap over the chest for some reason has gone up. The patient is placed against the tilting board that is lowered. Ambulance is called. Fracture on both legs. Prescriptive hospitals received information about the incident on 25. July. Then the business manager was informed. Physiotherapist controlled the direct fit of the tipping table's plastic bracket and velcro strap and could not find any defect or damage on the product. New instruction on risk and the importance of supervision on standing in the standing table have been developed for the staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001657382-2018-00007 |
| MDR Report Key | 8094755 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-07-04 |
| Date Mfgr Received | 2018-09-03 |
| Device Manufacturer Date | 2016-01-21 |
| Date Added to Maude | 2018-11-21 |
| 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 ULLA LANGE |
| Manufacturer Street | PARALLELVEJ 3 |
| Manufacturer City | GEDVED 8751 |
| Manufacturer Country | DA |
| Manufacturer Postal | 8751 |
| Manufacturer G1 | R82 A/S |
| Manufacturer Street | PARALLELVEJ 3 |
| Manufacturer City | GEDVED 8751 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 8751 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARIBOU |
| Generic Name | STANDING DEVICE |
| Product Code | INQ |
| Date Received | 2018-11-21 |
| Returned To Mfg | 2018-11-21 |
| Model Number | 31860104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R82 A/S |
| Manufacturer Address | PARALLELVEJ 3 GEDVED 8751 DA 8751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-21 |