MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE

Model Number NB8001

Device Problem Crack (1135)

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

Event Date 08/30/2017

Event Type  malfunction  

Event Description

Product complaint on item nb8001 for lot 139560- cracks on light shields.

Event Description

Product complaint on item nb8001 for lot 139560- cracks on light shields.

• Brand Name: MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE
• Type of Device: LIGHT SHIELD
• 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: 6903324
• MDR Text Key: 89393950
• Report Number: 1836161-2017-00108
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

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: Other
• Device Model Number: NB8001
• Device Lot Number: 139560
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 10/12/2017
• 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