MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-31 for STAIR PRO - MODEL 6250 NA manufactured by Stryker Corp. Medical Division.
[21679154]
It was reported that the backrest of the stair chair was cracked. No adverse consequence was alleged.
Patient Sequence No: 1, Text Type: D, B5
[21867178]
The customer was unresponsive; no product was able to be received for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1831750-2009-01059 |
| MDR Report Key | 1463327 |
| Report Source | 07 |
| Date Received | 2009-08-31 |
| Date of Report | 2008-05-28 |
| Date of Event | 2008-05-26 |
| Date Mfgr Received | 2008-05-28 |
| Device Manufacturer Date | 2006-12-15 |
| Date Added to Maude | 2009-10-27 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENATA SILA |
| Manufacturer Street | 3800 E. CENTRE AVE. |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693246689 |
| Manufacturer G1 | STRYKER CORP. |
| Manufacturer Street | 3800 E. CENTRE AVE. |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAIR PRO - MODEL 6250 |
| Generic Name | STAIR CHAIR |
| Product Code | IMK |
| Date Received | 2009-08-31 |
| Model Number | 6250 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP. MEDICAL DIVISION |
| Manufacturer Address | PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-31 |