MAUDE Adverse Event Report: INNOVATIVE MEDICAL PRODUCTS; DE MAYO KNEE POSITIONER

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

We received 2 sus voluntary event reports one (mw5092979) was reported as a malfunction and the other (mw5093012) was reported as a serious injury with a required intervention.The event descriptions are identical save a few spelling changes between them.This shows that they came from the same facility and/or person one day apart, however; with no contact information or other identifying characteristics filled out on either of the forms we cannot effectively contact, communicate or otherwise understand how someone was seriously injured.The event descriptions do not indicate that anyone was injured only pointing out a cleaning concern from spd.Because cleaning and sterilization validations have been done on the product the spd concerns likely stem from incorrect cleaning and sterilization i.E.Not following ifu.- : [maude mw5093012.Pdf, maude mw5092979.Pdf].

Event Description

Unknown, the person/ facility that sent maude report did not give any indication of what the injury was.

• Type of Device: DE MAYO KNEE POSITIONER
• Manufacturer (Section G): INNOVATIVE MEDICAL PRODUCTS; 87 spring lane; plainville industrial park; plainville, ct
• Manufacturer Contact: richard larkin ; 87 spring lane; plainville industrial park; plainville, ct ; 7930391206
• MDR Report Key: 10007109
• MDR Text Key: 189330128
• Report Number: 1223419-2020-00001
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1