MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for ULTRA COMFORT, SE 3 X 30 1703034300 manufactured by Stryker Medical-kalamazoo.
[136716029]
It was reported that the nurse tore their meniscus or ligament requiring treatment. Device could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[136716030]
It was reported that while transferring a (b)(6) patient from a stretcher with the mattress to an ambulance cot for transport to another facility. The mattress moved with the patient and both began to slide off. One of the nurses went to catch the patient and "tweaked" their knee.
Patient Sequence No: 1, Text Type: D, B5
[141572983]
Added the serial number and updated the result and conclusion code.
Patient Sequence No: 1, Text Type: N, H10
[141572984]
It was reported that while transferring a 360lb patient from a stretcher with the mattress to an ambulance cot for transport to another facility. The mattress moved with the patient and both began to slide off. One of the nurses went to catch the patient and "tweaked" their knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2019-00270 |
| MDR Report Key | 8355981 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-20 |
| 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. 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 | 0 |
| Brand Name | ULTRA COMFORT, SE 3 X 30 |
| Generic Name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Product Code | IKY |
| Date Received | 2019-02-20 |
| Catalog Number | 1703034300 |
| 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 | 2019-02-20 |