MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for HUDSON RCI BITEGARD ORAL BITE BLOCK manufactured by Teleflex Incorporated.
[177369169]
The patient was admitted on [date redacted] with an intra-cranial bleed. He was in the neurological critical care unit (nccu) until transfer to a neuro floor approximately a month later. One week later, while being seen for a dual therapy session (pt and ot), the patient coughed forcefully and expelled a 3cm x 3cm green portion of a bite block. Note that the white the portion of the bite block, which typically extends out of the mouth was no longer present. The patient reportedly did not relax his jaw during oral care and the presence of the block was unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659159 |
| MDR Report Key | 9659159 |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-08 |
| Report Date | 2020-01-31 |
| Date Reported to FDA | 2020-01-31 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON RCI BITEGARD ORAL BITE BLOCK |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2020-02-03 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |