MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-04-14 for JAY SEATING J2 BACK NA manufactured by Sunrise Medical.
[15032963]
Reporter claims the top hook flattened out and the back slipped through the backpost of the chair causing the end user to fall backwards and hit reporter's head. End user claims to have suffered a concussion and is currently receiving medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720745-2000-00001 |
| MDR Report Key | 273558 |
| Report Source | 08 |
| Date Received | 2000-04-14 |
| Date of Report | 2000-04-13 |
| Date of Event | 2000-03-27 |
| Report Date | 2000-04-13 |
| Date Mfgr Received | 2000-03-27 |
| Date Added to Maude | 2000-04-17 |
| 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 | 3 |
| Manufacturer Contact | WENDY CAVANAUGH, QS/RA |
| Manufacturer Street | 2842 BUSINIESS 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 | 2000-04-14 |
| Returned To Mfg | 2000-03-31 |
| Model Number | J2 BACK |
| Catalog Number | NA |
| Lot Number | P/N S2520TK |
| ID Number | P/N S2520TK |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 264809 |
| Manufacturer | SUNRISE MEDICAL |
| Manufacturer Address | 7477 E. 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; 2. Required No Informationntervention | 2000-04-14 |