MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-12 for PREMIER CARE CLINER 65603 manufactured by Winco Mfg, Llc.
[22192333]
Pt was scheduled at (b)(6) surgery center for a pain procedure. While pt was getting dressed her driver/roommate tried to adjust the foot rest, metal sliced her left index finger approx 1 centimeter below the distal first knuckle. This included the nail tip of the finger. The finger tip was placed in ice and the pt was directed to go directly to (b)(6) er via motor vehicle. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[22322317]
During a phone conversation between patty ober of (b)(6) surgery center and winco's director of engineering, (b)(4), the following clarification of the incident was given: while the pt was sitting in the clinical chair she requested the help of her roommate to assist with putting the chair into a reclined position. The roommate reached down using her right hand on the footrest and left hand grabbing the scissor mechanism and proceeded to lift up. At some point during this process, the roommate's left index finger approx 1 centimeter below the distal first knuckle was severed. The roommate was unable to determine definitively what part of the mechanism severed her finger. There was no nurse in the room at the time of the incident. The clinical chair was taken out of service due to possible litigation issues and not due to the operation and safety of the chair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2013-00001 |
| MDR Report Key | 3202311 |
| Report Source | 05 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-06-12 |
| Date of Event | 2013-05-02 |
| Date Facility Aware | 2013-05-02 |
| Report Date | 2013-06-12 |
| Date Reported to Mfgr | 2013-05-17 |
| Date Mfgr Received | 2013-05-26 |
| Date Added to Maude | 2013-07-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 5516 S.W. FIRST LN. |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 3528542929 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIER CARE CLINER |
| Generic Name | CLINICAL CHAIR |
| Product Code | FRJ |
| Date Received | 2013-06-12 |
| Model Number | 65603 |
| Catalog Number | 65603 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG, LLC |
| Manufacturer Address | 5516 S.W. FIRST LN. OCALA FL 34471 US 34471 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-06-12 |