MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-14-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-14-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: deflation.
Event or Problem Description
Healthcare provider reported an unknown side "expander had deflated." device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation results: the review of the documentation associated to the manufacturing process indicated that all devices in the work order were released in accordance with allergan procedures, and no anomalies were found in the documents related to the reported event.No device analysis was performed as the device was not returned.An awareness about this event was performed to the tissue expander personnel.According to the current risk documents the event of leakage (or opening) in the patch/shell assembly process was a known failure mode and manufacturing process controls and inspections are stablished to reduce the incidence of this failure mode.Considering that there is not an adverse trend for this type of event with only one record in jan/2020, no additional actions were deemed required time of investigation.The issue of opening on patch to shell bond area will continue to be monitored and corrective action taken in the future if deemed appropriate.Additional, changed, and/or corrected data: b.5., h.6.
Event or Problem Description
Healthcare provider reported an unknown side "expander had deflated." device has been explanted and discarded after surgery.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10592109
• Report Number: 9617229-2020-15533
• Device Sequence Number: 372586
• Product Code: LCJ
• UDI-Device Identifier: 10888628044203
• UDI-Public: 10888628044203
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2021

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 Model Number: 133S-MX-14-T
• Device Catalogue Number: 133S-MX-14-T
• Device Lot Number: 3401085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 03/27/2021
• 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: Required Intervention