MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2015-06-19 for COMMODE SLING WITH CHAINS 113-D manufactured by H. Fine & Sons Ltd.
[5866968]
It was reported to the manufacturer by the end user, per the end user, the patient was being moved from bed to chair when the sling tipped and chain came off the cradle hook, dropping the patient;. The patient's head hit the bar on the way down and she landed on her head. The patient was taken to the hospital where a ct scan was done and a c2 fracture was found. The patient also received 4 stitches above left eyebrow and 1 stitch on yop of here head. Complaint #(b)(4) were entered into our system to have the sling and lift returned to joerns for investigation. As of this writing, the sling and lift have not been returned.
Patient Sequence No: 1, Text Type: D, B5
[13473376]
Joerns sending the report to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009402404-2015-00017 |
| MDR Report Key | 4863024 |
| Report Source | 06,08 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-06-07 |
| Date Facility Aware | 2015-06-07 |
| Report Date | 2015-06-18 |
| Date Reported to FDA | 2015-06-18 |
| Date Reported to Mfgr | 2015-06-18 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-06-24 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN RD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMMODE SLING WITH CHAINS |
| Generic Name | SLING FOR A LIFT |
| Product Code | FNG |
| Date Received | 2015-06-19 |
| Model Number | 113-D |
| Catalog Number | 113-D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | H. FINE & SONS LTD |
| Manufacturer Address | LONDON UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-06-19 |