MAUDE Adverse Event Report: ALLERGAN RND RE-STER SIZER 20, 550

Catalog Number MSZ20550

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

Allergan's device analysis lab received a silicone sizer where the "hermoform [was] compromised".

Manufacturer Narrative

Sent to fda on 10/24/2014.

• Brand Name: RND RE-STER SIZER 20, 550
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 pkwy global; park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4213600
• MDR Text Key: 4981293
• Report Number: 2024601-2014-00607
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2019
• Device Catalogue Number: MSZ20550
• Device Lot Number: 2589317
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1