MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-08 for LD304 MATERNITY BED 4701000000 manufactured by Stryker Medical-kalamazoo.
[116450587]
It was reported that the nurse hit her leg on the abduction assembly of the bed, injuring her knee which required an arthroscopic meniscectomy surgery. No defects were alleged with the unit, and the patient was not affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00958 |
| MDR Report Key | 7763751 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-08-08 |
| 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. CHANDA BURGHARD |
| 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 | LD304 MATERNITY BED |
| Generic Name | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) |
| Product Code | HDD |
| Date Received | 2018-08-08 |
| Catalog Number | 4701000000 |
| 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 | 2018-08-08 |