MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-01-09 for LD304 MATERNITY BED 4701000000 manufactured by Stryker Medical-kalamazoo.
[96749175]
The matter is currently involved in litigation and being handled by the (b)(4) legal department. If further information becomes available, a supplemental report will be submitted as necessary. Matter is in litigation.
Patient Sequence No: 1, Text Type: N, H10
[96749176]
It was alleged via notice of claim that a patient was injured by a stryker bed during labor and delivery admission. No details regarding the alleged injury or any product malfunction were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00022 |
| MDR Report Key | 7175400 |
| Report Source | OTHER |
| Date Received | 2018-01-09 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2007-12-20 |
| Date Added to Maude | 2018-01-09 |
| 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. MARY KLAVER |
| 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 | 2018-01-09 |
| 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 | 2018-01-09 |