MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-03 for POSEY BED 8070 manufactured by Posey Products Llc.
[145506296]
Customer confirmed will not be returning product. Without the device the reported issue could not be confirmed and possible causes of the failure could not be determined. This product is a serviceable item and historical review of similar complaints against this product was determined to be related to normal wear and tear. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant. Manufacturer reference file # (b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[145506297]
The patient's guardian reported the canopy is ripping at the seams inside and outside. The netting has holes and the front of the canopy has been glued by the guardian. The canopy is in very bad condition. Additional information from the guardian, received on 2019/04/12, stated the issues with the canopy was discovered when the user fell through the canopy due to the split in the seams. Guardian confirmed the patient did not suffer any injury from the fall. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00123 |
| MDR Report Key | 8579234 |
| Report Source | CONSUMER |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2014-12-08 |
| Date Added to Maude | 2019-05-03 |
| 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 | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2019-05-03 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |