MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA RLP 280G RE-STER SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number N-SZRLP280

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Complaint was received on 05/12/2016.This medwatch is being sent to fda on day 32.As a result, a capa is being initiated.Device will reportedly be returned, but has not yet been received.Device labeling addresses: "each sizer is supplied sterile in a sealed, double primary package.Sterility of the sizer is maintained only if the packages, including the package seals, are intact.Avoid prolonged exposure to extreme storage conditions.We recommend that these devices are stored at ambient room temperatures, at atmospheric pressure and in dry conditions away from direct sunlight.Do not use the product if the packages or seals have been damaged.".

Event Description

Health professional reported, "outer packaging was intact, however sterile inner packaging was found to be half open," in reference to a re-sterilizable sizer.Device did not make patient contact.

Manufacturer Narrative

Device history record: "review of dhr for work order (b)(4) did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event.All gel breast implants were reviewed as part of the assembly operations and these tasks were performed according to applicable current procedures to ensure that assembly met the required specifications.The dhr assembly report from sap was verified and there was not any scrap related with reported event, all devices were conformance during manufacturing process.Review of seal strength records related to work order (b)(4) did not identified any deviations or non-conformities that may be associated with the reported device and seal strength test results were according to the applicable specifications." lab analysis findings: "device weighed 280.80 gm.There was white particles on the device shell.There were bubbles in the gel following autoclave disinfection process.".

Event Description

Health professional reported, "outer packaging was intact, however sterile inner packaging was found to be half open," in reference to a re-sterilizable sizer.Device did not make patient contact.

• Brand Name: NATRELLE INSPIRA RLP 280G RE-STER SIZER
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5721084
• MDR Text Key: 47291152
• Report Number: 9617229-2016-00075
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

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: 11/05/2019
• Device Catalogue Number: N-SZRLP280
• Device Lot Number: 2681152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention