MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-22 for * manufactured by *.
[532035]
This is a male that had a decompressive laminectomy done in 2005. An ultrasonic aspirator was used during the surgery. Initially he did well post-operatively and was discharged home 3 days later. Later he developed a wound dehiscence. Twenty-six days after discharge, he was taken back to surgery for repair of the dehiscence. The next day, he was discharged home in stable condition.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1040129 |
MDR Report Key | 755428 |
Date Received | 2006-08-22 |
Date of Report | 2006-07-05 |
Date of Event | 2005-10-31 |
Date Added to Maude | 2006-08-30 |
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 |
Reporter Occupation | RISK MANAGER |
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 | * |
Generic Name | ULTRASONIC ASPIRATOR |
Product Code | LBK |
Date Received | 2006-08-22 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 743255 |
Manufacturer | * |
Manufacturer Address | * * * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2006-08-22 |