FDA Adverse Event
Malfunction
Summary report: N
CANDYCANE 5MM 26CM LG
MDR report key: 6054118
·
Received October 25, 2016
Report
- Report Number
- 1645337-2016-00136
- Event Type
- Malfunction
- Date Received
- October 25, 2016
- Date of Event
- October 14, 2016
- Report Date
- October 25, 2016
- Manufacturer
- MENTOR WW LLC
- Product Code
- MUU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCTS NOT RETURNED.
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION PROVIDED, THE CANNULA TIP BROKE DURING A SURGICAL PROCEDURE. HOWEVER, IT DID NOT BREAK INSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE INVOLVED IN THIS COMPLAINT WILL NOT BE RETURNED TO MENTOR. SHOULD THE DEVICE BECOME AVAILABLE TO PE, THIS COMPLAINT WILL BE REEVALUATED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706938 | CANDYCANE 5MM 26CM LG | LIPSUCTION CANNULA | MUU | MENTOR WW LLC | 15072303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |