MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

Catalog Number 350-1490

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 01/27/2017

Event Type  Injury  

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. (b)(4). The device was not received by mentor yet.

Event Description

It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. By that time the patient was on the table. Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. However the delay caused a potential risk to the patient. The event required surgical intervention as the physician used a venous ports seal kit on the patient. Patient was required extended hospitalization. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). The patient is fine now. No other information was available about the patient. Device was sent back to mentor.

Manufacturer Narrative

On march 27, 2017, mentor worldwide llc has initiated a voluntary remedial action to remove one (1) lot of mentor® saline-filled spectrum¿ breast implants (575cc) lot number 7377332. Some units in the affected lot do not contain the dome pack accessory indicated on the box label. (b)(4).

• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 33 technology drive; irvine CA 92618
• 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: 6350753
• Report Number: 1645337-2017-00012
• 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,health

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 350-1490
• Device Lot Number: 7377332-010
• Other Device ID Number: 350-1490
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Hospitalization; Required Intervention