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 Type  malfunction  

Event Description

During a wound clinic visit, the left hip was debrided by the physician and the hip wound was measured by the nurse with the foam tipped measuring device.Unfortunately, the end of a foam-tipped applicator had freed itself from the end of the plastic tip.The nurse was not able to retrieve this.Physician was able to retrieve the tip.

Manufacturer Narrative

This is the first incident report from the distribution of over 3.5 million devices released in the last 5 years.Testing on retained samples did not reveal any device malfunction.

• Brand Name: PURITAN
• Type of Device: WOUND MEASURE DEVICE
• Manufacturer (Section D): PURITAN MEDICAL PRODUCTS COMPANY LLC; guilford ME
• Manufacturer Contact: william young ; 31 school st.; p.o. box 149; guilford, ME 04443 ; 2078763311
• MDR Report Key: 4188504
• MDR Text Key: 19484083
• Report Number: 1216735-2014-00002
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 63