MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-31 for 6950 XL ELITE CARE CLINER 6950-07-TB manufactured by Winco Mfg. Llc.
[15810297]
On (b)(4) 2013 winco's customer care department received a call from (b)(6). (b)(6) stated that a registered nurse at their (b)(6) center was injured when attempting to put a pt in the recline position of a winco 6950 xl elite care cliner. It was reported that the nurse severed the tip of her finger in the recline mechanism. The report was then turned over to winco's quality manager. (b)(4) followed up with (b)(6) on (b)(6). (b)(6) stated that the nurse was fine and that she had one of the hospital's best plastic surgeons repairing the damage. She then proceeded to narrate what the nurse relayed to her about the incident. "while trying to recline a heavier pt, the rn stood at the foot of the recliner to manage the position of the pt's legs. Another person was behind the recliner. The person behind the recliner proceed to recline the pt back before the rn was ready. The rn tried to reach for the iv line that was getting tangled in the recliner mechanism. At the same time, the person at the back of the recliner pushed hard on the seat back causing the recliner to recline rapidly, surprising the rn. Before she could remove her hand, the recliner mechanism caught the tip of her finger. There was no injury to the pt in the recliner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1027229-2013-00003 |
| MDR Report Key | 3445136 |
| Report Source | 06 |
| Date Received | 2013-10-31 |
| Date of Report | 2013-10-18 |
| Date of Event | 2013-10-16 |
| Date Mfgr Received | 2013-10-16 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2013-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GEORGE ANELLO, QUALITY MANAGER |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6950 XL ELITE CARE CLINER |
| Generic Name | CARE CLINER |
| Product Code | FRJ |
| Date Received | 2013-10-31 |
| Model Number | 695 |
| Catalog Number | 6950-07-TB |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| 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 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-10-31 |