MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-15 for ULTRA COMFORT, SE 4 X 26 W/FB 1704034601 manufactured by Stryker Medical-kalamazoo.
[136302341]
It was reported that a paramedic was injured while forcing on his back during patient transfers. The customer indicates that the mattress slips insufficiently and makes the patient transfer difficult. As a consequence, the paramedic went on sick leave for 15 days.
Patient Sequence No: 1, Text Type: D, B5
[141573335]
It was reported that the injury had occurred due to the mattress sliding off of the litter. It was stated that while attempting to transfer the patient the mattress had slid off the litter with the patient. The caregiver tried to catch the mattress and allegedly hurt his back. It was confirmed that the patient did not receive an injury as a result of this alleged event, but that the caregiver went on sick leave for 15 days due to his back injury. The customer did not record the serial number of the device at the time of the alleged event. Device could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[141573336]
It was reported that a paramedic was injured while forcing on his back during patient transfers. The customer indicates that the mattress slips insufficiently and makes the patient transfer difficult. As a consequence, the paramedic went on sick leave for 15 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2019-00269 |
| MDR Report Key | 8344456 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-15 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-15 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | ULTRA COMFORT, SE 4 X 26 W/FB |
| Generic Name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Product Code | IKY |
| Date Received | 2019-02-15 |
| Catalog Number | 1704034601 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-02-15 |