MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for MICROAIRE CANNULA PAL-R30MLS manufactured by Microaire Surgical Instruments.
[114287232]
While performing a liposuction procedure on a patient's inner knee, the cannula being used fractured. There was no patient injury. The broken cannula piece was removed and no additional medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2020601-2018-00005 |
MDR Report Key | 7687452 |
Date Received | 2018-07-13 |
Date of Report | 2018-07-13 |
Date of Event | 2018-06-16 |
Date Mfgr Received | 2018-08-15 |
Device Manufacturer Date | 2017-07-26 |
Date Added to Maude | 2018-07-13 |
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 | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. BRIAN AMELL |
Manufacturer Street | 3590 GRAND FORKS BLVD. |
Manufacturer City | CHARLOTTESVILLE VA 22911 |
Manufacturer Country | US |
Manufacturer Postal | 22911 |
Manufacturer G1 | MICROAIRE SURGICAL INSTRUMENTS |
Manufacturer Street | 3590 GRAND FORKS BLVD. |
Manufacturer City | CHARLOTTESVILLE VA 22911 |
Manufacturer Country | US |
Manufacturer Postal Code | 22911 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | MICROAIRE CANNULA |
Generic Name | 3.0MM MULTI-USE CANNULA |
Product Code | MUU |
Date Received | 2018-07-13 |
Model Number | PAL-R30MLS |
Catalog Number | PAL-R30MLS |
Lot Number | 0717311441 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MICROAIRE SURGICAL INSTRUMENTS |
Manufacturer Address | 3590 GRAND FORKS BLVD. CHARLOTTESVILLE VA 22911 US 22911 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-07-13 |