MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for BAR600IVC NA:BAR600IVC manufactured by Invacare Florida.
[117972075]
Further information about the event has been requested, at this time no additional details have been received. The bed as well as pictures of the bed before being dismantled for shipping have been received by invacare, an evaluation of the device is in process. When additional information becomes available, a supplemental record will be filed.????
Patient Sequence No: 1, Text Type: N, H10
[117972076]
Hospice stating that a patient cut his leg on a metal piece of the bed frame that is sticking out from the side of the bed. He was taken to the emergency room and received 11 sutures on his leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2018-00012 |
| MDR Report Key | 7808536 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2018-08-23 |
| 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 JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAR600IVC |
| Generic Name | AC POWERED BED |
| Product Code | OSI |
| Date Received | 2018-08-23 |
| Returned To Mfg | 2018-08-13 |
| Model Number | NA:BAR600IVC |
| Catalog Number | BAR600IVC |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-23 |