MAUDE Adverse Event Report: INTEGRA INTEGRA MILTEX O-RINGS; LIGATOR, HEMORRHOIDAL

Model Number 28-155

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Product has no instructions for use available per manufacturer.Product labeled non-sterile but manufacturer.Product labeled non-sterile but manufacturer sent certification letter saying product is sterilized, this labeled should be removed.Product is packaged with 100 items yet should only be used for one patient as currently packaged.Fda safety report id # (b)(4).Fda received date 01/30/2020.

• Brand Name: INTEGRA MILTEX O-RINGS
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): INTEGRA; york PA 17402
• MDR Report Key: 9666266
• MDR Text Key: 177883233
• Report Number: MW5092730
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: 28-155
• Device Lot Number: 208372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1