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Catalog Number 3341507
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Seroma (2069); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Event Date 07/21/2017
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.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) of lot number 6871997 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 by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017.This patient¿s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015.She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015.The patient had mentor tissue expanders that were implanted from (b)(6) 2015.The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r.Side serial # (b)(4)) implanted in (b)(6) 2015.On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours.The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017.The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week.The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis.The patient did not experience skin lesions, fevers, night sweats or weight loss.There was no pain, redness, palpable breast mass, or capsular contracture.The lymphoma cells were found in the seroma fluid surrounding the implant.Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results.This is a pathologically confirmed stage ie primary diagnosis of alcl.Based on histology, there is no capsular involvement.The lymphoma cells were found in the effusion fluid surrounding the implant.The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017.The implants were intact and not ruptured upon removal.
Manufacturer Narrative
On july 8, 2020, mentor became aware that following information was inadvertently not reported or incorrectly reported under the previous initial submission on september 6, 2017.The information has been corrected on this form.(b)(4).Reason for device explant and/or reoperation: right side anaplastic large-cell lymphoma manufacturer¿s reference number: (b)(4).
Manufacturer Narrative
After clinical/secondary review of this file performed on (b)(6), 2023, it was decided to add late onset seroma and surgical intervention, to more accurately capture the reported event.Per the legal document provided and review performed, on (b)(6), 2017 the patient had fluid aspirated from her right breast where a seroma had developed.The pathology results were positive for bia-alcl.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: right side anaplastic large-cell lymphoma, late onset seroma, and surgical intervention manufacturer¿s reference number: (b)(4) codes updated added under section h per clinician's review.
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Brand Name
Type of Device
Manufacturer (Section D)
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving, TX 75038
MDR Report Key6847224
MDR Text Key85081442
Report Number1645337-2017-00103
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/22/2019
Device Catalogue Number3341507
Device Lot Number6871997
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age56 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite