BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 3003816 · Received March 14, 2013

    Report

    Report Number
    1000306051-2013-00017
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    October 27, 2012
    Report Date
    February 13, 2013
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS ASSOCIATED WITH THIS EVENT WERE NOT REPORTED OR DOCUMENTED BY THE FACILITY. BASED ON DISTRIBUTION HISTORY, POTENTIAL LOTS WERE IDENTIFIED: S11098-470, S11098-538, S10967-587, AND S10977-359: S11098 MANUFACTURE DATE: 04/11/2012, EXPIRATION DATE: 03/31/2014; S10967 MANUFACTURE DATE: 07/21/2011, EXPIRATION DATE: 12/31/2012; S10977 MANUFACTURE DATE: 04/11/2012, EXPIRATION DATE: 02/28/2013. METHOD: REVIEW OF INFORMATION REPORTED TO LIFECELL. REVIEW OF THE DEVICE HISTORY RECORDS FOR POTENTIAL LOTS. REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR OTHER COMPLAINTS REPORTED AGAINST POTENTIAL LOTS S11098, S10967, AND S10977. RESULTS: INTERNAL INVESTIGATION RESULTED IN NO REMARKABLE FINDINGS AND NO DEVIATIONS DURING PROCESSING RELATED TO THE NATURE OF THIS EVENT. ALL 3 POTENTIAL LOTS MET QC RELEASE CRITERIA. QUERY OF LIFECELL COMPLAINT SYSTEM REVEALED AS OF (B)(4) 2013, NO SIMILAR COMPLAINTS WERE REPORTED TO LIFECELL AGAINST LOT S11098, S10967 OR S10977. (B)(4). CONCLUSION: BASED ON INFORMATION REPORTED, INCLUDING THE PATIENT'S MEDICAL CONDITION, AND INTERNAL INVESTIGATION INTO THE POTENTIAL COMPLAINT RELATED LOTS, LIFECELL HAS CONCLUDED IT IS UNLIKELY THAT THE DEVICES CONTRIBUTED TO THE EVENT. THE PATIENT'S CONDITION, INCLUDING INSUFFICIENT CIRCULATION POST OPERATIVELY LEADING TO NECROSIS AND INFECTION, DIRECTLY CONTRIBUTED TO THE EVENT. IT SHOULD BE NOTED THAT SEROMA IS A WELL KNOWN COMPLICATION ASSOCIATED WITH THESE TYPES OF SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION : REVIEW OF INFORMATION REPORTED TO LIFECELL. RESULTS : LIMITED INFORMATION REGARDING THE EVENT IS AVAILABLE. LIFECELL IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. CONCLUSION: INCONCLUSIVE. INVESTIGATION IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT #1 (B)(4). ADDITIONAL INFORMATION WAS REPORTED TO LIFECELL ON (B)(4) 2013 SURROUNDING THE EVENT: THE (B)(6) FEMALE PATIENT UNDERWENT A BILATERAL PROPHYLACTIC MASTECTOMY AND DIRECT-TO-IMPLANT RECONSTRUCTION WITH LIFECELL DEVICES AT IBSEN HOSPITAL ON (B)(6) 2012. THE PATIENT HAD DRAINAGE AND EARLY SIGNS OF INSUFFICIENT CIRCULATION TO THE BREAST (SAME DAY). EIGHT DAYS POST-OP ((B)(6) 2012), THE PATIENT HAD A RE-OPERATION DUE TO BLEEDING AND SEROMA ON THE LEFT SIDE. SUBSEQUENTLY, SEROMA, NECROSIS AND INFECTION OF THE BREAST DEVELOPED BILATERALLY. IT WAS REPORTED THAT THE PATIENT HAD A TOTAL OF 7 PROCEDURES (MINIMUM) AT (B)(6) HOSPITAL AND (B)(6) HOSPITAL. CULTURES TAKEN AT THE HOSPITAL CONFIRMED A BILATERAL (B)(6). ACCORDING TO DR (B)(6) OF HOSPITAL, THE PATIENT UNDERWENT A RIGHT SIDED MASTECTOMY AT (B)(6) HOSPITAL ON (B)(6) 2012 WHERE THE DEVICE(S) WAS LIKELY EXPLANTED. THE PATIENT HAD GENERALIZED EXANTHEMA (SKIN ERUPTION) FOR WEEKS. THE PATIENT WAS REFERRED TO (B)(6) HOSPITAL FOR RECONSTRUCTION; SHE WILL LIKELY NEED ANOTHER MICROSURGICAL PROCEDURE ON THE RIGHT SIDE, THEN THE BREASTS MUST BE RECONSTRUCTED. THE SURGEON DID NOT INCLUDE ANY DOCUMENTATION ABOUT THE DEVICE LOT NUMBERS IN THE MEDICAL INFORMATION, BUT IT WAS NOTED THAT THIS WAS THE ONLY CASE AT THIS HOSPITAL WHERE LIFECELL DEVICES WERE ORDERED. DUE TO QUESTIONS ABOUT PATIENT CONSENT, RIGHTEOUS INFORMATION, MEDICAL DOCUMENTATION AND FOLLOW UP, THE PATIENT IS REPRESENTED BY A LAWYER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED TO LIFECELL THAT A PATIENT UNDERWENT A PROPHYLACTIC MASTECTOMY AND DIRECT-TO-IMPLANT RECONSTRUCTION WITH STRATTICE. SUBSEQUENTLY, THE WOUND BROKE DOWN AND INFECTION OCCURRED. TREATMENT INCLUDED THE REMOVAL OF BOTH THE DEVICE AND IMPLANT. THE ORIGINAL PROCEDURE DATE AND DATE OF EXPLANT ARE UNKNOWN. REPORTEDLY, THE PATIENT HAS FILED A LEGAL SUIT. LIFECELL IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107343 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 08160001EU/10160001EU SEE H10 FOR POTENTIAL LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention