MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-11-24 for HUDSON RCI 1140 manufactured by Teleflex Medical.
[2660302]
Soft plastic portion of oral bite block detached and swallowed by pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2594644 |
| MDR Report Key | 2594644 |
| Report Source | 99 |
| Date Received | 2010-11-24 |
| Date of Report | 2010-11-24 |
| Date of Event | 2010-11-18 |
| Date Facility Aware | 2010-11-18 |
| Report Date | 2010-11-24 |
| Date Added to Maude | 2012-06-05 |
| 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 | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON RCI |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2010-11-24 |
| Catalog Number | 1140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PO BOX 12600 RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2010-11-24 |