MAUDE Adverse Event Report: PURITAN MEDICAL PRODUCTS COMPANY LLC PURITAN; WOUND MEASURE DEVICE

Model Number 1506 1PF DM

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2014

Event Type  No Answer Provided  

Event Description

Rn was measuring pt abdominal wound upwards toward 12 o'clock using plastic foam tipped measuring device.When removed applicator, realized that foam tip was no longer on stick.Used flashlight to look upward to see if could be retrieve any foam that may have been left in wound but unable to see any.Pt was admitted for surgical removal of sponge.Sponge remove from wound.

Manufacturer Narrative

This incident is a claim from over (b)(4) wound devices distributed over the last 3 years.Our investigation could not reproduce a defect that would account for this claim.

• Brand Name: PURITAN
• Type of Device: WOUND MEASURE DEVICE
• Manufacturer (Section D): PURITAN MEDICAL PRODUCTS COMPANY LLC
• Manufacturer Contact: william young ; 31 school st.; guilford, ME 04443
• MDR Report Key: 4404260
• MDR Text Key: 5301950
• Report Number: 1216735-2014-00003
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506 1PF DM
• Device Catalogue Number: 1506 1PF DM
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization