MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN TISSUE EXPANDERS; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK_TISSUE EXPANDERS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: unspecified adverse event.(b)(4).

Event Description

This event is associated with the (b)(6) clinical trial.It was reported that a (b)(6) year-old caucasian female patient underwent unspecified breast reconstruction surgery with an unknown cpx4 tissue expander and experienced an unspecified adverse event on her right side postoperatively.As a result, the tissue expander was explanted at an unknown date.

Manufacturer Narrative

After clinical/secondary review of this file performed on (b)(6) 2020, it was determined that there were no alleged product deficiency nor adverse event.Initial report was submitted in error.Hence, codes have been correctly updated on this form.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN TISSUE EXPANDERS
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10687372
• MDR Text Key: 211645436
• Report Number: 1645337-2020-13046
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_TISSUE EXPANDERS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93