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

Model Number NB8000

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that a light shield was discovered with a crack in the product found by the end user.The item was not in use.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).

• 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: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 8768562
• MDR Text Key: 150406401
• Report Number: 1836161-2019-00054
• 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
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB8000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• 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