MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for MIDLAND BARIATRIC STAND-IN TABLE 554512E manufactured by Patterson Medical.
[30708612]
Patient Sequence No: 1, Text Type: N, H10
[30708613]
Human factors issue with midland mfg co electric bariatric stand-in table. Dr was called to evaluate patient in the therapy gym. Patient was standing with therapist using a steadying platform. Her right great toe was underneath the platform, and when she went to move it, the proximal half of her great toe nail was sheared off. There was at first significant bleeding, however, with compression by nursing and therapist, this resolved. When dr came to examine the nail, there was clearly blood present, however, active bleeding appeared to have ceased for the time being. The distal half of the nail was still intact, though looked friable. No signs of infection. Continued monitoring. Pain is controlled. Clinical engineering recommendation is to have patients wear shoes when using the table and to paint/tape the base of the table where patients put their feet to be careful of the gap that exists and not to inadvertently hurt their toe(s).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5210411 |
| MDR Report Key | 5210411 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-09-19 |
| Report Date | 2015-10-29 |
| Date Reported to FDA | 2015-10-29 |
| Date Reported to Mfgr | 2015-10-29 |
| Date Added to Maude | 2015-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ROCCO OTTOLINO |
| Manufacturer Street | 3601 W 13 MILE ROAD |
| Manufacturer City | ROYAL OAK MI 480736769 |
| Manufacturer Country | US |
| Manufacturer Postal | 480736769 |
| Manufacturer Phone | 2485510550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDLAND BARIATRIC STAND-IN TABLE |
| Generic Name | powered table |
| Product Code | INQ |
| Date Received | 2015-11-09 |
| Model Number | 554512E |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PATTERSON MEDICAL |
| Manufacturer Address | W68 N158 EVERGREEN BLVD. CEDARBURG WI 53012 US 53012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-09 |