MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-02 for PRIMEBIG WHEEL ELECT STRETCHER 1115 1115000000E manufactured by Stryker Medical-kalamazoo.
[181572758]
Device not made available by customer.
Patient Sequence No: 1, Text Type: N, H10
[181572759]
It was reported that a patient received a 4cm laceration between two toes while attempting to push herself up in bed and cut her foot on the stirrup. No information has been provided regarding the severity or treatment of the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00306 |
| MDR Report Key | 9774800 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-03-02 |
| 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 | 3 |
| Brand Name | PRIMEBIG WHEEL ELECT STRETCHER |
| Generic Name | STRETCHER, WHEELED |
| Product Code | FPO |
| Date Received | 2020-03-02 |
| Model Number | 1115 |
| Catalog Number | 1115000000E |
| 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 | 2020-03-02 |