MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-07 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.
[107526952]
No model or serial number was provided.
Patient Sequence No: 1, Text Type: N, H10
[107526953]
It is alleged the patient was laying on mattress for three weeks and developed a stage 2 pressure injury. It was further reported that the patient received unknown medical care for the alleged pressure injury.
Patient Sequence No: 1, Text Type: D, B5
[113460641]
The director of clinical education practice & informatics at the user facility clarified that she believed the injury to be a stage 2 pressure injury but was not certain about the severity. When asked if the patient was treated for the reported injury, she responded that there was unknown medical treatment.
Patient Sequence No: 1, Text Type: N, H10
[113460642]
It is alleged the patient was laying on mattress for three weeks and developed a stage 2 pressure injury. It was further reported that the patient received unknown medical care for the alleged pressure injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00454 |
| MDR Report Key | 7491946 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-07 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-05-07 |
| 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 | 3 |
| Brand Name | UNKNOWN_MEDICAL_PRODUCT |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-05-07 |
| 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 | 2018-05-07 |