BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 6517995 · Received April 25, 2017

    Report

    Report Number
    1213643-2017-00268
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    October 26, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016615
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDENDUM TO THE PREVIOUS INFORMATION. THIS SUPPLEMENTAL EMDR IS BEING SENT DUE TO ADDITIONAL INFORMATION RECEIVED. PER CONTACT WHO HAD PREVIOUSLY REPORTED EVENT (MW #5068783), REPORTS ONGOING CONDITIONAL ISSUES (MW #5080580). WITH THE NEW INFORMATION PROVIDED, NO CHANGES WERE MADE TO PREVIOUS CONCLUSION OF FILE.

    Description of Event or Problem · 0

    AS WAS ORIGINALLY REPORTED IN 04/2017: THE FOLLOWING WAS REPORT TO DAVOL VIA MAUDE EVENT REPORT (MW5068783) ON (B)(6) 2010, I WAS INVOLUNTARILY IMPLANTED WITH A BARD PERFIX PLUG AND PATCH, THE REFERENCE # IS (B)(4) AND THE LOT # HUTI1991. WITHIN DAYS, IT WAS CLEAR THAT MY BODY WAS HAVING AN ADVERSE REACTION AND WITHIN A WEEK, IT WAS SEVERELY INFECTED AND BLEEDING AND DRAINING PUS. MY SCROTUM BECAME 4" AND THEN EVENTUALLY 7". THE WOUND DID NOT HEAL FOR MORE THAN ONE MONTH. NO DRAIN OR WOUND VAC WAS PUT IN. THE WOUND WAS ALLOWED TO CLOSE FROM THE OUTSIDE IN. WITHIN MONTHS, THE INFECTION WENT SYSTEMATICALLY INTO MY BLOOD STREAM AND CAUSED SEPSIS ONCE OR TWICE. I HAVE BEEN HOSPITALIZED INPATIENT AND OUTPATIENT AND TREATED BY INFECTIOUS DISEASE SPECIALISTS. THEY WERE NOT ABLE TO RID MY BODY OF THE INFECTION TO THIS DATE. IT CAUSES PAINFUL FLESH EATING PUSTULES AND BOILS WHICH HURT VERY MUCH AND ARE EMBARRASSING AND CONTAGIOUS. MY WIFE NOW HAS THE INFECTION. THERE IS NERVE DAMAGE AND PAIN, SCARRING AND ADHESIONS, IT HAS CONSTRICTED MY VAS AND MY SPERMATIC CORD AND I HAVE BEEN OFFERED SEVERAL RADICAL SURGERY PROCEDURES ALL OF WHICH ARE EXPLAINED AS HIGH RISK. I WOULD LOSE A LARGE PORTION OF MY GROIN MUSCLE AND TISSUE AND REQUIRE MORE MESH AND MORE SURGERY. IT IS LIKELY THAT I WILL LOSE MY TESTICLE. I WOULD ALSO LOSE ALL SENSATION TO MY GROIN AND PARTS OF MY LOWER BODY. I HAVE 3 MAJOR PAIN CENTERS THAT DEBILITATE ME AND HAVE KEPT ME FROM WORKING FOR 5 YEARS: SKIN AND NERVE PAIN FROM RIGHT KNEE TO RIGHT NIPPLE LIKE BURNING AND PIN PRICKING ALSO WITH SPASMS; PAIN DEEP INSIDE MY GUT AND STOMACH CENTERED AROUND THE SURGICAL SITE LIKE WRENCHING, TWISTING, TEARING PAIN WHICH MAKES ME FALL ON GROUND; TESTICLE/SPERM PAIN LIKE A CONSTANT FEELING OF A TEN POUND WEIGHT ON MY TESTES OR BEING COMPRESSED HARD MY HAND AND SOME DAYS IT WILL GO SHARPLY INTENSE LIKE I HAVE BEEN KICKED IN THE TESTES AND I WILL BECOME NAUSEOUS FOR HOURS AND VOMIT. LASTLY WORTH NOTING IS MY DECREASED LIBIDO FROM SEXUAL PAIN AND MARRIAGE DIFFICULTY. ALSO, SHOULD BE NOTED THAT I HAVE LOST OVER 30 POUNDS AND CANNOT EAT EVEN A SMALL OR MEDIUM PORTION OF FOOD WITHOUT VOMITING. ALSO, I HAVE DISGUSTING NIGHT SWEATS EVERY NIGHT AND MY BED AND SHEETS ARE DISGUSTING YOU COULD WRING THEM OUT PER FOLLOW UP WITH CONTACT: PATIENT STATES HE HAS HAD PAIN SINCE SHORTLY AFTER THE IMPLANT SURGERY IN 2010. PATIENT SAW HIS IMPLANTING SURGEON WHO REFERRED HIM BACK TO HIS PRIMARY DOCTOR FOR PAIN MANAGEMENT. THE PATIENT REPORTS HE WAS THEN REFERRED TO ANOTHER SURGEON AND AT THAT TIME CONFIRMED TO HAVE INFECTION AND NERVE DAMAGE IN THE AREA OF THE HERNIA REPAIR. PATIENT STATES THE SURGEON OFFERED TO PERFORM AN EXPLANT AND LATER DECLINED, NOTING AN ADDITIONAL SURGERY WOULD BE TOO RISKY FOR THE PATIENT. THE PATIENT WAS OFFERED CHEMICAL NERVE ABLATION PAIN MANAGEMENT IN WHICH HE DECLINED. THE PATIENT MOVED TO A NEW AREA AND HAS RECENTLY ESTABLISHED CARE WITH NUMEROUS DOCTORS, HOWEVER, STATES HE IS CURRENTLY ON GOVERNMENT INSURANCE AND IS REQUIRED TO WAIT LONG PERIODS OF TIME IN BETWEEN MD VISITS. PATIENT REPORTS SEEING A UROLOGIST WHO PERFORMED A PAIN INJECTION INTO THE TESTICLE WHICH DID RELIEVE THE PAIN IN THAT AREA AND THE UROLOGIST RULED OUT THE PAIN COMING DIRECTLY FROM THE TESTICLE AND DID NOT WANT TO PERFORM ADDITIONAL INTERVENTION IN THAT AREA. THE PATIENT IS NOW CONSIDERING HIS OPTION TO PURSUE THE CHEMICAL NERVE ABLATION PROCEDURE RATHER THAN SURGICAL INTERVENTION AND WILL DO SO AS HIS INSURANCE ALLOWS. THE PATIENT STATES HE HAS EXTREME PAIN WITH ANY SORT OF ACTIVITY IN WHICH HE DESCRIBES AS BURNING AND STABBING WHICH MAKES HIM NAUSEOUS WHEN IT OCCURS. THE PATIENT REPORTS THE INFECTION TO BE MRSA AND STATES IT HAS BEEN ONGOING WITHOUT FULL RESOLUTION. ADDENDUM PER MW5080580: THE FOLLOWING WAS REPORTED TO DAVOL VIDA MAUDE EVENT REPORT (MW5080580) WENT IN FOR OPEN, RIGHT INGUINAL, HERNIA REPAIR WITH SUTURE IN (B)(6) 2010. I WAS UNWITTINGLY IMPLANTED WITH THE C.R. BARD-DAVOL "PERFIX PLUG" LARGE SIZE PLUG AND PATCH. I HAD FOREIGN BODY REACTION , AND MASSIVE PURULENT INFECTION BOTH EXTERNALLY ON SKIN AND INTERNALLY, SEVERE PAIN AND NERVE DAMAGE. THE INFECTION WAS NEVER CURED EVEN AFTER MONTHS AND MONTHS OF HEAVY ANTIBIOTICS , AND EVEN ANTIBIOTIC INFUSION. I WENT SEPTIC AND ALMOST DIED. I STILL GET FLESH EATING BOILS. MY WIFE HAS EXTERNALLY CONTRACTED THE SKIN INFECTION FROM ME. ASIDE FROM THE INFECTION, MY PAIN IS UNTREATABLE. I CAN ONLY GET PARTIAL, TEMPORARY RELIEF FROM NERVE BLOCKS AND GABAPENTIN, BUT THIS DOESN'T REACH ALL MY PAIN CENTERS. EVEN DURING THESE TIMES, MY ACTIVITIES ARE NIL, SO AS NOT TO CAUSE ANY MORE NERVE DAMAGE OR TISSUE DAMAGE. I HAD TO STOP WORKING, FISHING, BICYCLING, AND OMIT EVERY SINGLE OTHER ACTIVITY. I CANNOT WALK THROUGH THE GROCERY STORE OR TAKE MY DOG FOR A WALK. I CANNOT SIT IN ANY TYPE OF CHAIR BESIDES A RECLINER, I CANNOT STAND STRAIGHT UP. THIS NOW AFFECTS MY SEVERE SPINAL ISSUES (BECAUSE OF POSTURE). I HAVE BEEN TOLD I MAY HAVE A RECURRING HERNIA, IMPLYING THE MEDICAL DEVICE MAY ALSO HAVE FAILED AND TORN OR MIGRATED. I COULD WRITE A BOOK ON THIS AS I HAVE BEEN DEALING WITH IT FOR ALMOST A DECADE. BUT I BELIEVE THIS IS THE "JIST" OF IT.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. AS REPORTED THE PATIENT SUFFERED A CRUSHING GROIN INJURY IN 2007 AND IT IS UNCLEAR HOW THAT INJURY COULD BE CONTRIBUTING TO THE PATIENT'S CURRENT CONDITION. DHR REVIEW FOUND THE DEVICE WAS SUPPLIED TO THE CUSTOMER STERILE WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS. THE WARNING SECTION OF THE IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." THE ADVERSE REACTION SECTION OF THE IFU LISTS ADHESIONS AS A POSSIBLE COMPLICATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORT TO DAVOL VIA MAUDE EVENT REPORT (MW5068783) ON (B)(6) 2010, I WAS INVOLUNTARILY IMPLANTED WITH A BARD PERFIX PLUG AND PATCH, THE REFERENCE # IS (B)(4) AND THE LOT # HUTI1991. WITHIN DAYS, IT WAS CLEAR THAT MY BODY WAS HAVING AN ADVERSE REACTION AND WITHIN A WEEK, IT WAS SEVERELY INFECTED AND BLEEDING AND DRAINING PUS. MY SCROTUM BECAME 4" AND THEN EVENTUALLY 7". THE WOUND DID NOT HEAL FOR MORE THAN ONE MONTH. NO DRAIN OR WOUND VAC WAS PUT IN. THE WOUND WAS ALLOWED TO CLOSE FROM THE OUTSIDE IN. WITHIN MONTHS, THE INFECTION WENT SYSTEMATICALLY INTO MY BLOOD STREAM AND CAUSED SEPSIS ONCE OR TWICE. I HAVE BEEN HOSPITALIZED INPATIENT AND OUTPATIENT AND TREATED BY INFECTIOUS DISEASE SPECIALISTS. THEY WERE NOT ABLE TO RID MY BODY OF THE INFECTION TO THIS DATE. IT CAUSES PAINFUL FLESH EATING PUSTULES AND BOILS WHICH HURT VERY MUCH AND ARE EMBARRASSING AND CONTAGIOUS. MY WIFE NOW HAS THE INFECTION. THERE IS NERVE DAMAGE AND PAIN, SCARRING AND ADHESIONS, IT HAS CONSTRICTED MY VAS AND MY SPERMATIC CORD AND I HAVE BEEN OFFERED SEVERAL RADICAL SURGERY PROCEDURES ALL OF WHICH ARE EXPLAINED AS HIGH RISK. I WOULD LOSE A LARGE PORTION OF MY GROIN MUSCLE AND TISSUE AND REQUIRE MORE MESH AND MORE SURGERY. IT IS LIKELY THAT I WILL LOSE MY TESTICLE. I WOULD ALSO LOSE ALL SENSATION TO MY GROIN AND PARTS OF MY LOWER BODY. I HAVE 3 MAJOR PAIN CENTERS THAT DEBILITATE ME AND HAVE KEPT ME FROM WORKING FOR 5 YEARS: SKIN AND NERVE PAIN FROM RIGHT KNEE TO RIGHT NIPPLE LIKE BURNING AND PIN PRICKING ALSO WITH SPASMS; PAIN DEEP INSIDE MY GUT AND STOMACH CENTERED AROUND THE SURGICAL SITE LIKE WRENCHING, TWISTING, TEARING PAIN WHICH MAKES ME FALL ON GROUND; TESTICLE/SPERM PAIN LIKE A CONSTANT FEELING OF A TEN POUND WEIGHT ON MY TESTES OR BEING COMPRESSED HARD MY HAND AND SOME DAYS IT WILL GO SHARPLY INTENSE LIKE I HAVE BEEN KICKED IN THE TESTES AND I WILL BECOME NAUSEOUS FOR HOURS AND VOMIT. LASTLY WORTH NOTING IS MY DECREASED LIBIDO FROM SEXUAL PAIN AND MARRIAGE DIFFICULTY. ALSO, SHOULD BE NOTED THAT I HAVE LOST OVER 30 POUNDS AND CANNOT EAT EVEN A SMALL OR MEDIUM PORTION OF FOOD WITHOUT VOMITING. ALSO, I HAVE DISGUSTING NIGHT SWEATS EVERY NIGHT AND MY BED AND SHEETS ARE DISGUSTING YOU COULD WRING THEM OUT PER FOLLOW UP WITH CONTACT: PATIENT STATES HE HAS HAD PAIN SINCE SHORTLY AFTER THE IMPLANT SURGERY IN 2010. PATIENT SAW HIS IMPLANTING SURGEON WHO REFERRED HIM BACK TO HIS PRIMARY DOCTOR FOR PAIN MANAGEMENT. THE PATIENT REPORTS HE WAS THEN REFERRED TO ANOTHER SURGEON AND AT THAT TIME CONFIRMED TO HAVE INFECTION AND NERVE DAMAGE IN THE AREA OF THE HERNIA REPAIR. PATIENT STATES THE SURGEON OFFERED TO PERFORM AN EXPLANT AND LATER DECLINED, NOTING AN ADDITIONAL SURGERY WOULD BE TOO RISKY FOR THE PATIENT. THE PATIENT WAS OFFERED CHEMICAL NERVE ABLATION PAIN MANAGEMENT IN WHICH HE DECLINED. THE PATIENT MOVED TO A NEW AREA AND HAS RECENTLY ESTABLISHED CARE WITH NUMEROUS DOCTORS, HOWEVER, STATES HE IS CURRENTLY ON GOVERNMENT INSURANCE AND IS REQUIRED TO WAIT LONG PERIODS OF TIME IN BETWEEN MD VISITS. PATIENT REPORTS SEEING A UROLOGIST WHO PERFORMED A PAIN INJECTION INTO THE TESTICLE WHICH DID RELIEVE THE PAIN IN THAT AREA AND THE UROLOGIST RULED OUT THE PAIN COMING DIRECTLY FROM THE TESTICLE AND DID NOT WANT TO PERFORM ADDITIONAL INTERVENTION IN THAT AREA. THE PATIENT IS NOW CONSIDERING HIS OPTION TO PURSUE THE CHEMICAL NERVE ABLATION PROCEDURE RATHER THAN SURGICAL INTERVENTION AND WILL DO SO AS HIS INSURANCE ALLOWS. THE PATIENT STATES HE HAS EXTREME PAIN WITH ANY SORT OF ACTIVITY IN WHICH HE DESCRIBES AS BURNING AND STABBING WHICH MAKES HIM NAUSEOUS WHEN IT OCCURS. THE PATIENT REPORTS THE INFECTION TO BE MW5068783 AND STATES IT HAS BEEN ONGOING WITHOUT FULL RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302484 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTI1991 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L| R| S