MAUDE Adverse Event Report: ALLERGAN NATRELLE IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hair Loss (1877); Neuropathy (1983); Arthralgia (2355); Cognitive Changes (2551); Weight Changes (2607)

Event Type  Injury  

Event Description

I started losing my hair.Pain in my joints, extreme fatigue, weight gain, hair loss, eye problems, extreme neuropathy, and confusion.Fda safety report id#: (b)(4).

• Brand Name: NATRELLE IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 11655328
• MDR Text Key: 245358686
• Report Number: MW5100719
• Device Sequence Number: 1
• Product Code: FTR
• 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
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90