MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for SIZEWISE PSYCH HOSPITAL BED HOSPITAL PSYCH BED manufactured by Sizewise Worldwide.
[109679907]
Safety screws on sizewise psych hospital bed were loose. Pt was able to remove 2 screws from interior head siderail. The screws were swallowed by the patient which required surgery for removal. All beds were checked. Several beds found to have loose screws. All screws on all sizewise psych beds were attached with adhesive and tightened to bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077517 |
| MDR Report Key | 7553258 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-05-03 |
| Date Added to Maude | 2018-05-30 |
| 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 | SIZEWISE PSYCH HOSPITAL BED |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2018-05-29 |
| Model Number | HOSPITAL PSYCH BED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIZEWISE WORLDWIDE |
| Manufacturer Address | 8601 MONROVIA ST. LENEXA KS 66215 US 66215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-29 |