MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-09 for WINCO 529 manufactured by Winco, Inc..
[1463702]
On the evening shift of (b)(6) 2007, pt was found to have sustained an amputation at or around the dip joint of the left ring finger. Blood was noted on the reclining mechanism of the chair in which pt was sitting.
Patient Sequence No: 1, Text Type: D, B5
[8692791]
Eval summary: on july 26th we received the 3500a form from (b)(6) hospital health center. They reported that a pt received an amputation of the left ring finger at the dip joint. On july 31st our (b)(4) rep inspected the suspect chair. He took pictures of the chair from all angles so that we could diagnose the possible cause of the injury. He discussed with the staff how this event occurred. From what they could determine, apparently a (b)(6) pt was locked into the full recline position; she became agitated and tried to get out of the chair by sliding forward. She then placed her left hand under the left mechanism to pull herself forward out of the chair; when her weight was shifted off the seat to the legrest/footrest, the position lock broke loose and the recline mechanism folded up with her finger in a scissors point. The pictures revealed that the recline mechanisms were bent outward from misuse; because the mechanisms were bent, the position lock did not properly engage to restrain the pt into the full recline position. A letter was sent to (b)(6) to advise them to replace the recline mechanisms and to check all the other winco recliners to make sure they are in good working condition. Conclusion: facility needs to follow the safety/care/maintenance instructions supplied with the chair. Winco engineering staff reviewed current chair to see if mechanism could be shielded; no ideas were submitted. Warning instructions are clear in the owner's manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2007-00001 |
| MDR Report Key | 1867633 |
| Report Source | 05,06 |
| Date Received | 2010-06-09 |
| Date of Event | 2007-07-08 |
| Date Mfgr Received | 2007-07-26 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2010-10-13 |
| 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 Street | 5516 SW 1ST LANE |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 3528542929 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINCO |
| Generic Name | RECLINER |
| Product Code | FRJ |
| Date Received | 2010-06-09 |
| Model Number | 529 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO, INC. |
| Manufacturer Address | 5516 SW 1ST LANE OCALA FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-06-09 |