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

Model Number	133S-MV-14-T
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Cellulitis (1768); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The events of seroma, cellulitis, wound dehiscence, exposure, and drainage 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.Reasons for reoperation: "had superficial seromas that drained spontaneously," "cellulitis," "surgical wound breakdown, exposure, and murky fluid draining from site.".
Event or Problem Description
Healthcare professional reported left side "had superficial seromas that drained spontaneously.A physician allowed drainage at the point patient had cellulitis on both breasts." healthcare professional additionally reported "biofilm," "surgical wound breakdown, exposure, and murky fluid draining from site." treatment had been provided in the form of "levoquin, iv clindamycin, and i&d." the device has been explanted.
Event or Problem Description
Healthcare professional reported left side "had superficial seromas that drained spontaneously.A physician allowed drainage at the point patient had cellulitis on both breasts." healthcare professional additionally reported "biofilm," "surgical wound breakdown, exposure, and murky fluid draining from site." treatment had been provided in the form of "levoquin, iv clindamycin, and i&d." the device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11282069
• Report Number: 9617229-2021-01328
• Device Sequence Number: 3842557
• Product Code: LCJ
• UDI-Device Identifier: 10888628043886
• UDI-Public: 10888628043886
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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 Expiration Date: 09/17/2024
• Device Model Number: 133S-MV-14-T
• Device Catalogue Number: 133S-MV-14-T
• Device Lot Number: 3381193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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
• Patient Weight: 75