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

Model Number	133S-MX-12-T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported that when they "opened the expander they noted something on it so they used the second one of the same size.At first look it seems to be ink, but when touched it, it moved so it seems to be lent or strand of fabric." device was not implanted.
Event or Problem Description
Healthcare professional reported that when they "opened the expander they noted something on it so they used the second one of the same size.At first look it seems to be ink, but when touched it, it moved so it seems to be lent or strand of fabric." device was not implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: device appearance (fiber or strand) on shell.Additional analysis was performed which identified: device appearance to describe that it was observed a foreign material on implant (fiber or strand) which measures 1.0mm, according to qa 199.12 is within the specification since the spec is> 2mm.Based on the device analysis the final assessment is: observed a fibrous material which measured 1mm and according to qa199.12 was within specification.Additional, changed, and/or corrected data: d.10, h.3, h.6.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-12-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9997218
• Report Number: 9617229-2020-06998
• Device Sequence Number: 11872528
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: 10888628044180
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 04/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2024
• Device Model Number: 133S-MX-12-T
• Device Catalogue Number: 133S-MX-12-T
• Device Lot Number: 3392765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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