MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32/E; PE LINER

Catalog Number 01.26.3244HCT

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 28 december 2017.(b)(4).

Event Description

The inlay did not fit into the cup, the size was correct.After a few times trying, a new pe liner e was opened and it worked.

• Brand Name: LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32/E
• Type of Device: PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7150720
• MDR Text Key: 96367300
• Report Number: 3005180920-2017-00792
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

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 Expiration Date: 08/29/2022
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 173567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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
• Patient Outcome(s): Other