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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

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MENTOR WORLDWIDE LLC BREAST IMPLANT Back to Search Results
Catalog Number 3507001BC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); No Code Available (3191)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).
 
Manufacturer Narrative
On 1/2/2018, mentor became aware that a second device was involved. As a result, manufacturer¿s reference number 1645337-2018-00652 was created to document it. Concomitant products: mentor memorygel smooth round moderate plus profile 700cc gel-filled breast implant, catalog # 3507001bc, lot # 6623741 manufacturer¿s reference number: (b)(4).
 
Manufacturer Narrative
On 1/2/2018, mentor became aware that a second device was involved. As a result, manufacturer¿s reference number 1645337-2018-00652 was created to document it. Concomitant products: mentor memorygel smooth round moderate plus profile 700 cc gel-filled breast implant, catalog # 3507001bc, lot # 6623741. (b)(4).
 
Manufacturer Narrative
On 3/29/2018, 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. Manufacturer¿s reference number: (b)(4).
 
Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device weighed 730. 6 grams. The gel contained in the device appeared clear. No foreign material was observed within the device. Gel was observed on the shell surface. The product evaluation team (pe) discovered a rent measuring 18cm located on the anterior aspect, extending to the posterior aspect, produced during the decontamination process. No other anomalies were discovered. A root cause failure analysis will not be conducted since the investigation could not confirm that an actual failure of the device to conform to expected performance had occurred. Allergic response is a state of hypersensitivity induced by exposure to a particular antigen resulting in harmful immunologic reactions on subsequent or continued exposures. Materials used in the manufacture of silicone saline breast implants are considered biocompatible, however, anecdotal reports of allergic response are reported in the literature. Due to the multiple exposures of the patient to drugs, chemicals and materials in the intra-operative and postoperative phase, it is often difficult to determine the specific antigen causing an allergic response. 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. Manufacturer¿s reference number: (b)(4).
 
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 product has not been returned.
 
Event Description
It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. Date of explant is scheduled for (b)(6) 2017. Multiple attempts have been made to obtain clarification on this event. However, no further information has been made available.
 
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Type of DeviceBREAST IMPLANT
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
carl hansen
north irving, TX 75038-3540
9497893858
MDR Report Key6795847
MDR Text Key113432733
Report Number1645337-2017-00054
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/20/2019
Device Catalogue Number3507001BC
Device Lot Number6855894-063
Other Device ID Number3507001BC
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/15/2017 Patient Sequence Number: 1
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