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

Catalog Number 350-3310

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2017

Event Type  malfunction  

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 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.

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 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.

• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: joaquin kurz ; north irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6813485
• MDR Text Key: 83689458
• Report Number: 1645337-2017-00060
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 03/17/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1