MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-12-T, 300CC; EXPANDER, SKIN, INFLATABLE

Catalog Number J133S-MV-12-T

Device Problems No Apparent Adverse Event (3189); Incomplete or Inadequate Connection (4037)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been/will be initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.The reason for reoperation is: "had a checkup and thought i'd start with the saline solution ready for the first injection, but when i used the magnet it reacted in the opposite direction.The direction of the magnet is opposite in s and m [¿] looking at the ct scan, it doesn't look like it's going in the other way around, and it looks like the magnets are in the right place.Today, i tried to inject it into the place where the magnet was, but i cannot attract it.I thought it would be a small amount, so i injected about 30cc of saline while watching the echo, but i felt that it was leaking under the skin, so i took a ct scan at that stage.It is thought that saline may have entered the subcutaneous area of the front and injection could not be performed well" (magnetic connection mechanism is not connecting to inject liquid into the tissue expander device).

Event Description

Healthcare professional reported against an unknown side, "had a checkup and thought i'd start with the saline solution ready for the first injection, but when i used the magnet it reacted in the opposite direction.The direction of the magnet is opposite in s and m [¿] looking at the ct scan, it doesn't look like it's going in the other way around, and it looks like the magnets are in the right place.Today, i tried to inject it into the place where the magnet was, but i cannot attract it.I thought it would be a small amount, so i injected about 30cc of saline while watching the echo, but i felt that it was leaking under the skin, so i took a ct scan at that stage.It is thought that saline may have entered the subcutaneous area of the front and injection could not be performed well." device remains implanted.

Manufacturer Narrative

Additional and/or changed data.This record is no longer reportable to the fda and will be un-reported.

Event Description

Previous medwatch submission "had a checkup and thought i'd start with the saline solution ready for the first injection, but when i used the magnet it reacted in the opposite direction.The direction of the magnet is opposite in s and m, looking at the ct scan, it doesn't look like it's going in the other way around, and it looks like the magnets are in the right place.Today, i tried to inject it into the place where the magnet was, but i cannot attract it.I thought it would be a small amount, so i injected about 30cc of saline while watching the echo, but i felt that it was leaking under the skin, so i took a ct scan at that stage.It is thought that saline may have entered the subcutaneous area of the front and injection could not be performed well".Upon further review by abbvie medical safety, this event is considered minor in severity and is not reportable.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-12-T, 300CC
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16859812
• MDR Text Key: 314449252
• Report Number: 9617229-2023-08315
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 04987836037416
• UDI-Public: 4987836037416
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J133S-MV-12-T
• Device Lot Number: 3594168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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): Required Intervention
• Patient Sex: Female