FDA Adverse Event
Malfunction
Summary report: N
ACC III 3MM 32CM L HD CANNULA
MDR report key: 5021589
·
Received August 12, 2015
Report
- Report Number
- 1645337-2015-00153
- Event Type
- Malfunction
- Date Received
- August 12, 2015
- Report Date
- August 12, 2015
- Manufacturer
- MENTOR WORLDWIDE LLC
- Product Code
- MUU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO CODE AVAILABLE FOR NO VISIBLE DEFECTS.
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION PROVIDED, THE CANNULA TIP BROKE DURING SURGERY. THE DATE OF SURGERY WAS NOT PROVIDED. A PHOTO WAS PROVIDED AND PRODUCT EVALUATION COULD NOT VISIBLY CONFIRM ANY A BROKEN TIP. WITHOUT THE RETURN OF THE DEVICE, A ROOT CAUSE FAILURE CANNOT BE CONCLUSIVELY DEMONSTRATED. NO PATIENT INJURY WAS REPORTED. SHOULD THE PRODUCT BECOME AVAILABLE TO PE, THIS COMPLAINT WILL BE REEVALUATED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 530609 | ACC III 3MM 32CM L HD CANNULA | LIPOSUCTION CANNULA | MUU | MENTOR WORLDWIDE LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |