MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for FCEALTMAXX manufactured by Medline Industries Inc..
[117256167]
It was reported that while the patient was using his electric/power scooter, he ran into the bed frame. Reportedly, the patient, who takes blood thinners, caught his right leg into the metals on the side of the bed frame sustaining laceration to his right leg. The patient went to the emergency room twice and received a total of 32 stitches to his right leg to close the laceration. The reporting facility stated that they have not identified any issue with regards to the design or manufacture of the bed. Due to the reported medical intervention and in an abundance of caution, this medwatch is being filed. The sample is not available to be returned for evaluation. There is no information to suggest that the bed frame caused or could have contributed to the event. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[117256168]
It was reported that a patient using a power scooter ran into the bed frame sustaining laceration that required stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00091 |
| MDR Report Key | 7786838 |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-08-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | ALTERRA MAXX UNIVERSAL BED |
| Product Code | OSI |
| Date Received | 2018-08-15 |
| Catalog Number | FCEALTMAXX |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-15 |