MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-01-09 for EYE STRETCHER CHAIR 5051 5051000000 manufactured by Stryker Medical-kalamazoo.
[3107050]
It was reported by service report that the head end jack was drifting.
Patient Sequence No: 1, Text Type: D, B5
[21983637]
It was reported by service report that the head end jack was drifting.
Patient Sequence No: 1, Text Type: D, B5
[22362826]
This emdr is an duplicate complaint as the jack drift issue was previously investigated and reported in mdr 1831750-2013-90284 and (b)(4). Please see mdr 1831750-2013-90284 for additional details regarding this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001831750-2013-00011 |
| MDR Report Key | 2903284 |
| Report Source | 00 |
| Date Received | 2013-01-09 |
| Date of Report | 2012-12-17 |
| Date of Event | 2012-12-17 |
| Date Mfgr Received | 2012-12-17 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-03-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ANTHONY NOORA |
| 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 | 3 |
| Brand Name | EYE STRETCHER CHAIR |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2013-01-09 |
| Model Number | 5051 |
| Catalog Number | 5051000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-01-09 |