MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-16 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.
[105635121]
The account could not provide the serial number of the surface as they had only recorded the serial number of the bed at the time of the reported event. However, no product malfunction is alleged. The serial number of the mattress was not recorded.
Patient Sequence No: 1, Text Type: N, H10
[105635122]
It was reported the patient developed a deep tissue injury while on the mattress. The patient had previously been found at their home, unconscious on their couch for an unknown amount of time. The pressure injury alleged developed shortly after admission, and the director of the icu reported they do not believe the stryker mattress caused or contributed to the alleged event. The patient was treated with a silicone bandage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00201 |
| MDR Report Key | 7434608 |
| Date Received | 2018-04-16 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-04-16 |
| 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 | 2018-04-16 |
| Catalog Number | UNK_MED |
| Device Availability | Y |
| 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 | 2018-04-16 |