MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-02-12 for ACT II ASSISTANT STOOL E-1 4205295 manufactured by Siemens Pelton & Crane.
[43555]
It was reported by the drs office that a dental assistant was sitting on a stool when the body support bolt broke. The assistant fell on the pt and then fell into the floor. There were no injuries reported. This stool has been repaired and is now working according to specs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00065 |
| MDR Report Key | 68700 |
| Report Source | 08 |
| Date Received | 1997-02-12 |
| Date of Report | 1997-02-12 |
| Date Mfgr Received | 1997-01-13 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 1997-02-19 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACT II ASSISTANT STOOL |
| Generic Name | DENTAL STOOL |
| Product Code | KLC |
| Date Received | 1997-02-12 |
| Model Number | E-1 |
| Catalog Number | 4205295 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 68673 |
| Manufacturer | SIEMENS PELTON & CRANE |
| Manufacturer Address | PO BOX 7800 CHARLOTTE NC 282417800 US |
| Baseline Brand Name | ACT II ASSISTANT STOOL |
| Baseline Generic Name | DENTAL STOOL |
| Baseline Model No | E-1 |
| Baseline Catalog No | 4205295 |
| Baseline ID | * |
| Baseline Device Family | DENTAL OPERATORY STOOL |
| 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 | 1997-02-12 |