MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-11-20 for 2000 CHAIR NA manufactured by Reliance Medical Products, Inc..
[115315]
A pt fell backwards due to the support bar on a procedures chair coming loose. This was caused by failure to tighten the support bar thumbscrew by the user facility. This is not a design or a mfg problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523545-1998-00001 |
| MDR Report Key | 198221 |
| Report Source | 00 |
| Date Received | 1998-11-20 |
| Date of Report | 1998-11-20 |
| Date of Event | 1998-09-29 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1998-11-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2000 CHAIR |
| Generic Name | EXAMINATION/PROCEDURES CHAIR |
| Product Code | HME |
| Date Received | 1998-11-20 |
| Model Number | 2000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 192572 |
| Manufacturer | RELIANCE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 3535 KINGS MILLS RD. MASON OH 450402303 US |
| Baseline Brand Name | 2000 EXAMINATION AND PROCEDURES CHAIR |
| Baseline Generic Name | CHAIR, EXAMINATION |
| Baseline Model No | 2000 |
| Baseline Catalog No | NA |
| Baseline ID | S/N 20019601006 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1998-11-20 |