MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-29 for ENDO TUBE FIXATION DEVICE - BITE BLOCK 1011 manufactured by Ipi Medical Products.
[30458722]
Patient found with bite block cracked and broken, hanging loosely. Able to replace without any airway concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057678 |
| MDR Report Key | 5201572 |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-10-27 |
| Date Added to Maude | 2015-11-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | ENDO TUBE FIXATION DEVICE - BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2015-10-29 |
| Catalog Number | 1011 |
| Lot Number | E161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IPI MEDICAL PRODUCTS |
| Manufacturer Address | DELRAY BEACH FL 33445 US 33445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-29 |