MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-06 for M-1 COT - BASE HIGH LOAD 28 6100 6100003000 manufactured by Stryker Medical-kalamazoo.
[182561345]
It was reported that the patient was transferred to the cot outside of the ambulance, the headboard of the cot was raised and locked into place. After raising the foot section, the head section of the cot dropped down. The patient was startled when the cot dropped and raised their head abruptly and hit their forehead on the lever of a table. This caused the patient to suffer a head laceration. The laceration was on the left side of the forehead above the eyebrow. The size of the laceration was described as approximately 3 x 3 cm and had the shape of a right angle. The laceration was stitched at the target hospital in the surgical department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00309 |
| MDR Report Key | 9800455 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-02-16 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | M-1 COT - BASE HIGH LOAD 28 |
| Generic Name | STRETCHER, WHEELED |
| Product Code | FPO |
| Date Received | 2020-03-06 |
| Model Number | 6100 |
| Catalog Number | 6100003000 |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2020-03-06 |