MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-16-T; EXPANDER, SKIN, INFLATABLE

Catalog Number	133S-MV-16-T
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device evaluation: visual analysis of the returned device identified: broken suture tap, curved opening, around 0-25% of the suture tap is missing.A leak test was performed and were found more than three openings.A microscopic analysis identified: more than three punctured on insert side assessed as surgical damage like, broken suture tap with striated edge assessed as surgical damage and more than three curved sharp openings on suture taps assessed as unidentified(tear) opening.Based on the device analysis the final assessment is: more than three punctured assessed as surgical damage like and missing shell that is assessed as inconclusive further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Company representative reported on behalf of the physician that when the physician "attempted to begin filling the tissue expander with the fourte needle and our magna finder.After marking the magnesite he inserted fourte into the skin.At that point the fourte missed the magnesite and punctured the tissue expander."doctor feels this was due to a small injection port/and a blunting of fourte needles which made skin difficult to penetrate, skin was moving." the device had to be removed.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-16-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8723454
• Report Number: 9617229-2019-07963
• Device Sequence Number: 16596225
• Product Code: LCJ
• UDI-Device Identifier: 10888628043909
• UDI-Public: 10888628043909
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2024
• Device Catalogue Number: 133S-MV-16-T
• Device Lot Number: 3334495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other