MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-13 for ULTRA COMFRT, SE 4X30 DOMESTIC 1704034300 manufactured by Stryker Medical-kalamazoo.
[183368193]
It was reported by medwatch form 3500 submitted by the user facility that during transfer of a patient from a stretcher to an operating room (or) table, the mattress slid with the patient and the patient was subsequently stuck between the stretcher and operating room (or) table. The staff successfully transferred the patient, however a contracted employee sustained an unknown muscular/skeletal injury. No injury was reported for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00313 |
| MDR Report Key | 9831485 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA COMFRT, SE 4X30 DOMESTIC |
| Generic Name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Product Code | IKY |
| Date Received | 2020-03-13 |
| Catalog Number | 1704034300 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |