MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for PATIENT ROOM WALL SAVER RECL 3500000730 manufactured by Stryker Medical-kalamazoo.
[79036842]
It was reported that the ottoman will not support the weight of the patient's legs/feet. There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[91205083]
A stryker field service representative reached out to the customer to schedule and evaluation for this device to confirm the alleged event. However, upon contact with the customer, the customer alleged that there was no component level defect with this unit and that the chair had since been returned to regular circulation so the inspection was unable to be performed. The customer further reported that no further assistance was needed at this time. Unit unavailable for evaluation
Patient Sequence No: 1, Text Type: N, H10
[91205084]
It was reported that the ottoman will not support the weight of the patient's legs/feet. There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00285 |
| MDR Report Key | 6681867 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-06-05 |
| Date Mfgr Received | 2017-06-05 |
| Device Manufacturer Date | 2017-04-18 |
| Date Added to Maude | 2017-06-30 |
| 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. CHANDA BURGHARD |
| 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 | PATIENT ROOM WALL SAVER RECL |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2017-06-30 |
| Catalog Number | 3500000730 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-06-30 |