MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-30 for OBT OBT200 manufactured by Joerns Healthcare, Inc..
[890983]
It was reported to mfr, by facility; per facility, a resident slid a cup of coffee across the obt [over bed table] and the cup "caught on the edge of the table top" and spilled onto his lap causing 2nd and 3rd degree burns. The state of mi has been called. Per the mfr, the edge of the t-mould remains proud of the table top edge for multiple reasons. First, the lip aids in spill protection, the lip helps to retain fluid on the table top if a spill occurs. Secondly, it is very important that the core material of the table top is not exposed to moisture/fluids as this can create a potential for water damage to the core material. Such exposure can also create the potential for fostering bacteria. The other issue and a concern for the mfr was the question as to why a facility would be servicing any liquid at this temperature that would cause second and third degree burns to their residents.
Patient Sequence No: 1, Text Type: D, B5
[7885106]
This is a non medical device complaint. However, the degree of injury to resident was serious.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182305-2008-00023 |
| MDR Report Key | 1070906 |
| Report Source | 06 |
| Date Received | 2008-06-30 |
| Date of Report | 2008-06-06 |
| Date of Event | 2008-05-23 |
| Date Facility Aware | 2008-05-23 |
| Date Mfgr Received | 2008-05-23 |
| Date Added to Maude | 2008-07-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHERYL NUGENT |
| Manufacturer Street | 5001 JOERNS DR. |
| Manufacturer City | STEVENS POINT WI 54481 |
| Manufacturer Country | US |
| Manufacturer Postal | 54481 |
| Manufacturer Phone | 7153413600 |
| Manufacturer G1 | JOERNS HEALTHCARE, INC. |
| Manufacturer Street | 5001 JOERNS DR. |
| Manufacturer City | STEVENS POINT WI 54481 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54481 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBT |
| Generic Name | OVER BED TABLE |
| Product Code | INW |
| Date Received | 2008-06-30 |
| Model Number | OBT200 |
| Catalog Number | OBT200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1038265 |
| Manufacturer | JOERNS HEALTHCARE, INC. |
| Manufacturer Address | 5001 JOERNS DR. STEVENS POINT WI 54481 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2008-06-30 |