MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for LD304 MATERNITY BED 4701000000 manufactured by Stryker Medical-kalamazoo.
[94643038]
It was reported that the nurse was unable to close the patient left abduction assembly and as she came back around the left side of the bed she hit the patient left calf support and hyperextended her knee. As a result the nurse got an mri, a cortisone shot, and phyiscal therapy. Upon evaluation of the customer's maternity beds, no defects could be found. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[108652650]
Supplemental submitted to include udi.
Patient Sequence No: 1, Text Type: N, H10
[108652691]
It was reported that the nurse was unable to close the patient left abduction assembly and as she came back around the left side of the bed she hit the patient left calf support and hyperextended her knee. As a result the nurse got an mri, a cortisone shot, and physical therapy. Upon evaluation of the customer's maternity beds, no defects could be found. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00553 |
| MDR Report Key | 7104983 |
| Date Received | 2017-12-11 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-12-11 |
| 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. KRISTEN CANTER |
| 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 | 0 |
| Brand Name | LD304 MATERNITY BED |
| Generic Name | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) |
| Product Code | HDD |
| Date Received | 2017-12-11 |
| Catalog Number | 4701000000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-11 |