MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA DR FOG W/ BOTTLE, BULK STERILE; ANTI-FOG

Model Number DF-3100B

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 08/24/2017

Event Type  malfunction  

Event Description

Customer reported on remark (b)(4), that during their inspection, they found something - looks like adhesive tape sealed in the plastic part of the pack.

• Brand Name: DR FOG W/ BOTTLE, BULK STERILE
• Type of Device: ANTI-FOG
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: megan morrissey ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6885913
• MDR Text Key: 87882784
• Report Number: 1836161-2017-00094
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K932449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DF-3100B
• Device Lot Number: 130549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• 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