MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Failure of Implant (1924); Pain (1994); Seroma (2069); Skin Discoloration (2074); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 03/24/2021

Event Type  Injury  

Event Description

Surgical removal of products; (b)(6) medical center in (b)(6): single right sided mastectomy w/ complete axillary dissection (b)(6) 2021 (dr.(b)(6)) w immediate implant-based breast reconstruction with a mentor breast tissue expander and flex hd acellular dermal matrix (adm) (plastic surgeon dr.(b)(6)).Week 2 after surgery experienced discoloration and swelling of breast.One jp drain had to remain in place for 5wks post op and was removed due to length of time even though still producing more than 40ccs a day.Breast continued to swell and had seroma aspirated 6wks post op.7wks post op pain, swelling, purple discoloration, and increased redness and was admitted to (b)(6) medical center (b)(6) 2021 for iv antibiotics and eventual removal of the expander and adm (b)(6) 2021.The plastic surgeon said the discoloration was right where the adm was and operative note stating "the inferior aspect of the adm was not wellincorporated with the overlying skin and subcutaneous tissue." fda safety report id#: (b)(4).

• Brand Name: MENTOR BREAST TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR WORLDWIDE LLC
• MDR Report Key: 11663819
• MDR Text Key: 245530535
• Report Number: MW5100747
• Device Sequence Number: 2
• Product Code: LCJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR
• Patient Weight: 77