MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-29 for 3 POSITION RECLINER FURN10100BLT manufactured by Medline Industries, Inc..
[17580880]
The end user fell while she was getting up from the recliner and fractured her coccyx.
Patient Sequence No: 1, Text Type: D, B5
[17900593]
It was reported that the end user pushed up to stand from a seated position and the brakes on the casters did not hold. She fell, fracturing her coccyx. It is unk if the casters were securely engaged in the locked position at the time of the incident. The fracture healed by itself. A sample has not been returned for evaluation. The manual states that routine maintenance and inspection of the casters should be performed. The contact at the facility was not aware that this had been done since they began using it in 2011. We have not confirmed the presence of a manufacturing defect or failure. A root cause has not been determined, however the lack of maintenance and inspection of the casters cannot be ruled out as a cause or contributing factor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00044 |
| MDR Report Key | 4808819 |
| Report Source | 05,06 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-03-11 |
| Date Mfgr Received | 2015-04-23 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2015-06-02 |
| 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 | JULIE FINLEY, |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3 POSITION RECLINER |
| Generic Name | NI |
| Product Code | KMN |
| Date Received | 2015-05-29 |
| Catalog Number | FURN10100BLT |
| Lot Number | A110744614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-29 |