PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION RECEIVED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT FEW DAYS POST IMPLANT OF PHASIX MESH, PATIENT WAS DIAGNOSED WITH NECROSIS, ISCHEMIA AND PAIN. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. NOTE, THE MANUFACTURING DATE (15-JUN-2014) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE PHASIX MESH (DEVICE #2). ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE PERFIX PLUG (DEVICE #1). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH DIRECT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿AN INDIRECT SAC WAS SEEN AND CORD LIPOMA WAS DISSECTED FREE. THE LARGE DIRECT DEFECT WAS NOTED. THE LARGE PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE DEFECT, SECURED WITH INTERRUPTED SUTURES. THE ONLAY PATCH WAS THEN PLACED INTO THE CANAL, SECURED IN ALL DIRECTIONS WITH THE INTERRUPTED SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT ILIOINGUINAL NERVE ENTRAPMENT THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE EDGES OF THE MESH WERE DISSECTED OUT LATERALLY AND SUPERIORLY. ILIOINGUINAL NERVE INTO THE AREA AND SOME OTHER FIBROUS BANDS WERE DIVIDED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT GROIN PAIN THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, ¿FLAP WAS CREATED SUPERIORLY AND THEN INFERIORLY FREED UP THE CORD AND MESH (DEVICE #1) THROUGH CONSIDERABLE SCAR TISSUE TO THE INFERIOR EDGE OF THE MESH. THE MESH (DEVICE #1) WAS INTACT. THE TAILS OF PREVIOUSLY PLACED MESH HAD SEPARATED AND THERE WAS A SMALL DEFECT LATERAL TO THE INTERNAL RING WAS REAPPROXIMATED WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A LARGE CAVITY IN THE SUBCUTANEOUS TISSUES OVERLYING THE FASCIA THAT HAD PURULENT DEBRIS WITHIN IT. THERE WERE SEVERE INFLAMMATORY CHANGES. THE OVERLAY PORTION OF THE MESH FROM INFERIOR ATTACHMENTS WERE MOBILIZED AND EXCISED THE POLYPROPYLENE OVERLAY. THE PLUG IN THE DIRECT SPACE WAS VERY MINIMALLY INCORPORATED IN THE PREPERITONEAL SPACE AND WAS DISSECTED FROM DENSE MEDIAL ATTACHMENTS ALONG THE COOPER LIGAMENT, AND THE FASCIAL INSERTIONS ON THE PELVIS. THE PLUG WAS COMPLETELY EXCISED.¿ (B)(6) 2015 - PATIENT UNDERWENT OPEN REPAIR FOR WASHOUT OF LEFT GROIN AND RECONSTRUCTION OF INGUINAL CANAL USING PHASIX FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿PHASIX LONG-TERM BIO-REABSORBABLE MESH (DEVICE #2) WAS PLACED AS OVERLAY TO RECONSTRUCT THE FLOOR OF INGUINAL CANAL AND THEN USED SUTURES TO APPROXIMATE THE MESH IN AN INTERRUPTED FASHION TO COOPER LIGAMENT AND THE MEDIAL ATTACHMENTS AT THE PELVIS AND THEN ALONG THE INFERIOR ASPECT, ANCHORED THE MESH TO THE ILIOPUBIC TRACT. SUPERIORLY, TACKED THE MESH TO THE INTERNAL OBLIQUE MUSCLE AND FASCIA.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ISCHEMIA, PAIN AND NECROSIS THEREBY UNDERWENT SCROTAL ORCHIECTOMY. PER OPERATIVE NOTES, ¿THE ISCHEMIC NECROSIS TESTICLE WAS DISSECTED FROM SURROUNDING TISSUES WAS FOUND TO BE GROSSLY EDEMATOUS. THERE WAS A PRESENCE OF NECROSIS OF THE CORD AS WELL.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, ABSCESS, LOSS OF TESTICLE, MESH MIGRATION, PAIN, RING BREAK, INFECTION AND EMOTIONAL INJURIES.