MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-02 for RHINOTEC ENT BLADE E9350 manufactured by Linvatec Corp..
[17328]
Ent blade broke during procedure. Staff unable to locate metal tip. X-ray ordered by physician. Object not visible on x-ray. Object was found by staff person after pt was transferred to recovery. Object measures approx 1/8" in diameter by 3/8" in length.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30835 |
| MDR Report Key | 30835 |
| Date Received | 1996-02-02 |
| Date of Report | 1995-09-28 |
| Date of Event | 1995-09-28 |
| Date Facility Aware | 1995-09-28 |
| Report Date | 1995-09-28 |
| Date Reported to Mfgr | 1995-09-28 |
| Date Added to Maude | 1996-03-07 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | RHINOTEC ENT BLADE |
| Generic Name | BONE CUTTING BLADE |
| Product Code | KTG |
| Date Received | 1996-02-02 |
| Catalog Number | E9350 |
| Lot Number | 17040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31890 |
| Manufacturer | LINVATEC CORP. |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 346434908 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-02-02 |