MAUDE Adverse Event Report: ALLERGAN NATRELLE 133 PLUS MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number N-67-133P-MV14

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Pain (1994); Respiratory Distress (2045)

Event Date 09/28/2018

Event Type  Injury  

Event Description

I had a double mastectomy from a dcis.After removing both breasts, the dr put in a tissue expander from allergan 133 plus mv.Normally i would stay in the clinic 7 days, but i was feeling really bad so i stayed there 14 days.I had a permanent feeling of very painful pressure, a breathing problem and a persistent headache.I then researched the product on the internet and found that it was not made in the (b)(4).There was no explanation that the expander and the implants are made in (b)(4).A medical device from (b)(4).I don't think it is safe, i don't want this in my body.So i removed this unsafe device which is made in (b)(4) out of my body.I don't want a product from an unsafe country in my body.I would never use an implant made in china, anyway so i don't an unsafe product from (b)(4).

• Brand Name: NATRELLE 133 PLUS MV TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 8133787
• MDR Text Key: 129572986
• Report Number: MW5081848
• Device Sequence Number: 2
• Product Code: LCJ
• Combination Product (y/n): N
• 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: 12/02/2018
• 2 Devices were Involved in the Event: 1 2

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
• Device Model Number: N-67-133P-MV14
• Device Lot Number: 3202893
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 80