MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-07-10 for JAY SEATING J2 BACK NA manufactured by Sunrise Medical, Mpd.
[181289]
Rptr states the top hooks on a j2 back broke while the chair was in use. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720745-2000-00007 |
| MDR Report Key | 285389 |
| Report Source | 00 |
| Date Received | 2000-07-10 |
| Date of Report | 2000-07-10 |
| Date of Event | 2000-06-13 |
| Date Mfgr Received | 2000-06-13 |
| Date Added to Maude | 2000-07-13 |
| 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 | 0 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WENDY CAVANAUGH |
| Manufacturer Street | 2842 BUSINESS PARK AVE |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592922171 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAY SEATING |
| Generic Name | WHEELCHAIR ACCESSORY |
| Product Code | KNO |
| Date Received | 2000-07-10 |
| Model Number | J2 BACK |
| Catalog Number | NA |
| Lot Number | P/N M-254 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276179 |
| Manufacturer | SUNRISE MEDICAL, MPD |
| Manufacturer Address | 7747 DRY CREEK PKWY. LONGMONT CO 80503 US |
| Baseline Brand Name | JAY SEATING |
| Baseline Generic Name | WHEELCHAIR ACCESSORY |
| Baseline Model No | J2 BACK |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SEATING/POSITIONING SYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901634 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-10 |