MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for LAZY BOY RECLINER - MEDICAL GRAD DD1307U manufactured by Knu, Llc.
[127855408]
A (b)(6) male admitted with diverticulitis was sleeping in a recliner chair in his room. He was fully reclined with leg rest extended. He woke up to the back rest collapsing in stages. He heard 3 pops, the back rest fell in stages with each pop. He partially slid out of the chair reporting that he slightly hit his head on the floor or the linen container. He reports no injury. It was determined that the interior 2 brackets on the backs of recliners that hold the back to the seat were loosening via loose screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081376 |
| MDR Report Key | 8078548 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-28 |
| Date Added to Maude | 2018-11-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LAZY BOY RECLINER - MEDICAL GRAD |
| Generic Name | CHAIR AND TABLE, MEDICAL |
| Product Code | KMN |
| Date Received | 2018-11-15 |
| Model Number | DD1307U |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KNU, LLC |
| Manufacturer Address | FERDINAND IN 47532 US 47532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |