MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-08 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.
[69735267]
It was reported that when the patient tried to step out of the chair the back of the chair rose up and ejected the patient out of the chair. Although there was patient involvement no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[92199225]
The issue was resolved for the customer by confirming that nothing further was needed at this time.
Patient Sequence No: 1, Text Type: N, H10
[92199226]
It was reported that when the patient tried to step out of the chair the back of the chair rose up and ejected the patient out of the chair. Although there was patient involvement no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[108000262]
Supplemental submitted to include udi.
Patient Sequence No: 1, Text Type: N, H10
[108000263]
It was reported that when the patient tried to step out of the chair the back of the chair rose up and ejected the patient out of the chair. Although there was patient involvement no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00062 |
| MDR Report Key | 6389570 |
| Date Received | 2017-03-08 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-03-08 |
| 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. KRISTEN CANTER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN_MEDICAL_PRODUCT |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2017-03-08 |
| Catalog Number | UNK_MED |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-08 |