MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	350-3310
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) of lot number 7378730 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).The product is not returned.
Event or Problem Description
It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc).The follow-up confirmed that the hair was on the implant upon opening a pouch.It was advised that once the issue was identified, the implant was sent to the back.Gloves were changed, and procedure was completed with a new implant.This didn't add much time to the procedure.There was no patient contact.
Additional Manufacturer Narrative
Device evaluation summary: according to the information received, it was reported by the customer that a mentor implant had a hair on it out of the box.The device was returned opened without the original box to product evaluation.No hair was visible on the shell or otherwise.No other anomalies were discovered.Product was unable to confirm any unusual failure mode, and the customer complaint could not be confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310cc).The follow-up confirmed that the hair was on the implant upon opening a pouch.It was advised that once the issue was identified, the implant was sent to the back.Gloves were changed, and procedure was completed with a new implant.This didn't add much time to the procedure.There was no patient contact.

• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6813485
• Report Number: 1645337-2017-00060
• Device Sequence Number: 12570518
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 350-3310
• Device Lot Number: 7378730-019
• Other Device ID Number: 350-3310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 03/17/2018
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1