MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. MEDLINE ANTI-FOG REGULAR SOLUTION; MEDLINE ANTI-FOG REGULAR SOLUTION,ST

Model Number MD-1001B

Device Problems Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2015

Event Type  malfunction  

Event Description

We were made aware that 2 ea of this item came to us damaged.Samples were discovered internally and reported concern was confirmed.Sterile barrier breach.

• Brand Name: MEDLINE ANTI-FOG REGULAR SOLUTION
• Type of Device: MEDLINE ANTI-FOG REGULAR SOLUTION,ST
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 5011602
• MDR Text Key: 24709474
• Report Number: 1836161-2015-00077
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD-1001B
• Device Lot Number: 65669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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