MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA DR FOG TREATED SPONGE, STERILE

Model Number DF-3120

Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer rejected 1 piece due to packing failure (sterility breach).

• Brand Name: DR FOG TREATED SPONGE, STERILE
• Type of Device: DR FOG
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 5745676
• MDR Text Key: 48742587
• Report Number: 1836161-2016-00056
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DF-3120
• Device Lot Number: 93035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2016
• 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