MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.
[129147244]
It was reported a patient's skin broke down while on the mattress.
Patient Sequence No: 1, Text Type: D, B5
[135023705]
It was reported to the account manager that the account placed an ehob overlay underneath the patient, on top of the mattress, following the discovery of the injury. The patient was discharged the next day and the account did not speak of any medical treatment for the alleged injury. A review of photos of the reported injury by a stryker clinical nurse consultant, found that she believed the patient had shown discoloration in the shape of the gel that resembles reactive hyperemia. No malfunction or defect was alleged. Serial number of the unit was not recorded.
Patient Sequence No: 1, Text Type: N, H10
[135023706]
It was reported a patient's skin broke down while on the mattress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-01447 |
| MDR Report Key | 8126800 |
| Date Received | 2018-12-03 |
| Date of Report | 2019-02-01 |
| Date of Event | 2018-11-03 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-12-03 |
| 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 | 0 |
| Brand Name | UNKNOWN_MEDICAL_PRODUCT |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-12-03 |
| Catalog Number | UNK_MED |
| 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 | 2018-12-03 |