MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2008-11-12 for A-DEC 1601 DOCTOR'S STOOL 65.0021.02 manufactured by A-dec, Inc..
[2140998]
Initial report did not indicate true level of injury, subsequent report (b)(6) 2008 indicated. Dr. (b)(6) was awaiting mri and possible rotator cuff surgery as a result of equipment defect and subsequent failure. Event: a doctor's stool base failed on one of five webs and caused dr. Anthony to fall and strike his shoulder on floor.
Patient Sequence No: 1, Text Type: D, B5
[9240877]
The stool base that fractured on one of five arms is manufactured by: leggett & platt, (b)(4). The stool base fracture was a manufacturer's defect traceable to a mold ejection and/or cold flow issue in the mold cavity around arm webbing. These bases are inspected, cleaned, powder-coated and assembled into various stool models by a-dec, inc.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015729-2008-00001 |
| MDR Report Key | 2176689 |
| Report Source | 01,06 |
| Date Received | 2008-11-12 |
| Date of Report | 2008-11-12 |
| Date of Event | 2008-10-10 |
| Date Mfgr Received | 2008-11-11 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2011-07-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS LOUISELL, MANAGER |
| Manufacturer Street | 2601 CRESTVIEW DR. |
| Manufacturer City | NEWBERG OR 97132 |
| Manufacturer Country | US |
| Manufacturer Postal | 97132 |
| Manufacturer Phone | 5035389471 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A-DEC 1601 DOCTOR'S STOOL |
| Generic Name | STOOL |
| Product Code | KLC |
| Date Received | 2008-11-12 |
| Returned To Mfg | 2008-11-11 |
| Model Number | 1601 |
| Catalog Number | 65.0021.02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A-DEC, INC. |
| Manufacturer Address | 2601 CRESTVIEW DR. NEWBERG OR 97132 US 97132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-12 |