MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA C-VIEW 20X30CM

Model Number 2258

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned, pictures provided.

Event Description

Customer reported they found open pouches of the c-view film 20x30cm, lot: 125803; exp-date: 2020-02.The picture depicts two films in one pouch where sealing was performed on the film itself, causing an open pouch.

• Brand Name: C-VIEW 20X30CM
• Type of Device: C-VIEW
• 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: 6832171
• MDR Text Key: 84120561
• Report Number: 1836161-2017-00081
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: 2258
• Device Lot Number: 125803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/30/2017
• 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