MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-04-25 for G98338MF manufactured by Medline Industries Inc..
[106405429]
It was reported that the end-user experienced a fall from the padded transfer bench while she was taking a shower. Reportedly, the back of the padded transfer bench broke off and the end-user fell into her bathtub. Paramedics were called and she was taken to the local hospital. An x-ray was performed with no acute fractures reported. No other diagnostic testing reported. Reportedly, the end-user was diagnosed with "whip-lash" to her neck, placed into a hard cervical collar, and was admitted to the hospital for observation. The sample was reportedly discarded and was not returned to the manufacturer for evaluation. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[106405430]
It was reported that the end-user experienced a fall and was admitted to the hospital for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00033 |
| MDR Report Key | 7457710 |
| Report Source | OTHER |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-25 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-04-25 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BENCH,TRANSFER,PADDED |
| Product Code | IKX |
| Date Received | 2018-04-25 |
| Catalog Number | G98338MF |
| Lot Number | 88517050031 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-25 |