MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-11-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-11-T
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Foreign Body Sensation in Eye (1869); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gt hold 9 28 concomitant of medical products: lot rh 217299-010, expiration 2021-12.Reference (b)(4) 16 x 20 cm perforated thick, date of therapy: (b)(6).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.The events of "wound dehiscence, exposure, and infection" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: "infection due to wound dehiscence and exposure".
Event or Problem Description
Hospital sales representative reported " revision is the result of removal of an infected tissue expander." healthcare provider also reported ¿wound dehiscence and exposure".Device has been explanted.This record is for the right side.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-11-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10590605
• Report Number: 9617229-2020-15402
• Device Sequence Number: 2656076
• Product Code: LCJ
• UDI-Device Identifier: 10888628044173
• UDI-Public: 10888628044173
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: P990074
• 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
• Report Date (Section B): 09/25/2020

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: 05/24/2024
• Device Model Number: 133S-MX-11-T
• Device Catalogue Number: 133S-MX-11-T
• Device Lot Number: 3353236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• 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: Required Intervention