PerFix 0117080Recalls & reported problems
Davol Inc. · PerFix Light Plug, 1.5" x 2.0" (3.8 cm x 5.0 cm), Extra Large (Contents: 1) · Class 2 · Implant
All models of PerFix (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 1
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741030970), received between Sep 14, 2018 and Aug 14, 2026 — classified as 1 death, 13 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility8
- Defective Device7
- Insufficient Device Problem Information4
- Device Contamination with Chemical or Other Material3
- Patient Device Interaction Problem2
- Delivered as Unsterile Product1
- Material Protrusion/Extrusion1
- Migration1
Patient problems
- Pain7
- Hernia5
- Disability4
- Injury4
- Adhesion(s)2
- Discomfort2
- No Clinical Signs, Symptoms or Conditions2
- Obstruction/Occlusion2
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258107 ↗InjuryJul 27, 2026Migration
Per information provided:(b)(6) 2009 - Patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of Kugel Patch (Device 1). Per op notes, ¿A transverse incision was made above the midportion of the left inguinal ligament. An indirect hernia sac was identified and reduced back into the peritoneum. A Kugel Patch (Device 1) was placed into the preperitoneal pocket and secured with sutures.¿ (b)(6) 2010 - Patient was diagnosed with recurrent left inguinal hernia, indirect type thereby underwent open repair with implant of PerFix Light Plug (Device 2). Per op notes, ¿An inguinal incision was made. An indirect sac was identified and cleared from medial to lateral. A PerFix Light Plug (Device 2) was placed into the preperitoneal space. The previously placed mesh (Device 1) could be palpated along the cephalad border of the defect and the PerFix Light Plug (Device 2) was secured to this piece of mesh (Device 1).¿ (b)(6) 2011 - Patient was diagnosed with prostate cancer thereby underwent radical prostatectomy. Per op notes, ¿A midline incision was made. Left pelvic space was created and noted to have a mesh (Device 1 and 2) which extends from the abdominal w
Patient problems: Adhesion(s)
MAUDE report 50021945 ↗InjuryJul 1, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA, UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "THE LEFT GROIN WAS ADDRESSED. A SMALL HERNIA WAS FREED ALL THE WAY DOWN TO INTERNAL RING. THE INGUINAL RING WAS SLIGHTLY PATULOUS AND A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE INTERNAL RING. AN ONLAY PATCH WAS PLACED AROUND THE SPERMATIC CORD STRUCTURES USING SUTURES. THE UMBILICAL HERNIA WAS NOTED. THE DEFECT WAS CLOSED USING SUTURES." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT RECURRENT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUGS (DEVICE 2 AND DEVICE 3). PER OP NOTES, "THE MESH PLUG (DEVICE 1) WAS COMPLETELY STUCK WITH DOWN TO THE SURROUNDING TISSUES WITH SEVERE TISSUE REACTION. THE MESH REACTION WAS NOTED. AN DIRECT HERNIA WAS IDENTIFIED. THE FLOOR WAS THICKENED FROM REACTION, SO A LARGE PERFIX LIGHT PLUG (DEVICE 2) WAS PLACED INTO THE AREA. THE INTERNAL RING WAS SURROUNDED BY OLD MESH (DEVICE 1). A SMALL PORTION OF THE PERFIX LIGHT PLUG (DEVICE 3) WAS PLACED AND SECURED TO ASSURE THE RECURRENCE OF I
Patient problems: Hernia; Scar Tissue
MAUDE report 25679136 ↗InjuryMar 26, 2026Patient-Device Incompatibility
AS REPORTED PER ANSM REPORT ((B)(4)): AS REPORTED, ON (B)(6) 2025 THE PATENT UNDERWENT STRANGULATED INGUINAL HERNIA REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUG. DATE OF OCCURRENCE: (B)(6) 2025. DESCRIPTION OF THE INCIDENT: CHRONIC RHEUMATIC INFLAMMATION (ALL JOINTS). DATE: (B)(6) 2025: CLINICAL HISTORY: THE PATIENT WAS SEEN IN THE ER FOR INCARCERATED RIGHT INGUINAL HERNIA AND UNDERWENT REDUCTION WITH MONITORING AND REFERRAL FOR HERNIA REPAIR IN SCHEDULED SURGERY. SUPINE POSITION, GENERAL ANESTHESIA, OROTRACHEAL INTUBATION. PROCEDURE: RIGHT INGUINAL INCISION VIA DIRECT APPROACH AFTER INFILTRATION WITH NAROPAIN 7.5. CROSSING OF THE VARIOUS MUSCULO-APONEUROTIC PLANES. A CRURAL HERNIA WAS INDEED FOUND WITH A HERNIAL SAC CONTAINING OMENTAL FAT, WHICH WAS RESECTED. INSERTION OF A LARGE PLUG (PERFIX LIGHT PLUG) INTO THE CRURAL ORIFICE, SECURED WITH CARDINAL SUTURES. CLOSURE LAYER BY LAYER. SKIN STAPLES PATHOLOGICAL ANATOMY AND CYTOLOGY UNIT EXCERPT FROM THE EXAMINATION REPORT ON THE SAMPLE TAKEN ON (B)(6) 2025. CLINICAL INFORMATION: TREATMENT OF STRANGULATED INGUINAL HERNIA WITH PROSTHESIS. INGUINAL LYMPHADENOPATHY FIXED IN PET SCAN. INVESTIGATION FOR HEMATOLOGICAL DISEASE OR INFLAMMATOR
Patient problems: Foreign Body Reaction; Rheumatoid Arthritis; Thrombocytopenia
MAUDE report 24700315 ↗InjurySep 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. A VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL WALL AND SECURE IT WITH SUTURE.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RIGHT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG LIGHT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. A PERFIX LIGHT PLUG MESH (DEVICE 2) WAS PLACED INTO THE PREPERITONEAL SPACE AND SECURE IT WITH SUTURE.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF PERFIX PLUG LIGHT MESH (DEVICE 2) AND IMPLANT OF ONE PHYSIO MESH. PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. PERFIX PLUG LIGHT MESH (DEVICE 2) WAS REMOVED TOTALLY. ONE PHYSIO MESH WAS PLACED INTO THE INGUINAL SIDE AND SECURE IT WITH SUTURE.¿
Patient problems: Adhesion(s); Hernia; Pain
MAUDE report 22975576 ↗InjuryJan 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, PATIENT UNDERWENT LEFT INGUINAL HERNIA SURGERY WITH IMPLANT OF PERFIX LIGHT PLUG, POST IMPLANT OF THE MESH PATIENT EXPERIENCED WITH PAIN, SWELLING IN THE LEFT INGUINAL AREA. IT WAS FURTHER REPORTED THAT, PATIENT UNDERWENT ULTRASOUND FOR REPORTED ISSUE WHICH REVEALED THE SUB INCISIONAL HEMATOMA AND WAS PLACED ON A NEGATIVE PRESSURE DRAINAGE BALL AFTER REMOVING THE STITCHES. IT WAS REPORTED THAT PATIENT WAS RECOVERING WELL.
Patient problems: Hematoma; Pain; Swelling/ Edema
MAUDE report 21110539 ↗DeathSep 2, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH LARGE INTRASCROTAL RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG LIGHT. PER OPERATIVE NOTES, ¿HERNIA WAS DISSECTED UP TO THE FLOOR OF THE INGUINAL CANAL AND THEN REDUCED ON MASS BACK INTO THE ABDOMEN. AN EXTRA-LARGE PERFIX PLUG WAS THEN PLACED INTO THE DEFECT AND TACKED IN SEPARATE PLACES ALONG CONJOINED TENDON AND THE SHELVING EDGE OF THE INGUINAL LIGAMENT. THE IN USING THE ONLAY PATCH AN OPENING WAS MADE TO ACCOMMODATE THE CORD STRUCTURES AND IT WAS PLACED AROUND THE CORD.¿ ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH BLADDER OUTLET OBSTRUCTION SECONDARY TO BPH, ACUTE URINARY RETENTION THEREBY RESECTION OF TRANSURETHRAL PROSTATE. PER OPERATIVE NOTES, ¿THE POSTERIOR URETHRA WAS NOTED TO HAVE A GROSS OBSTRUCTION.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION AND PERFORATION, HERNIA RECURRENCE, FISTULAE, INFECTION, PAIN & SUFFERING. IT WAS ALSO ALLEGED THAT THE PATIENT HAD SEPSIS, INFECTION, ABDOMINAL PAIN, RIGHT GROIN PAIN, URINARY RETENTION, TRANSURETHRAL RESECTION OF THE PROSTATE, PROSTATE HYPERTROPHY, URINARY TRACT SYMPTOMS, DIVERTICULITIS,
Patient problems: Obstruction/Occlusion; Urinary Retention
MAUDE report 20118094 ↗MalfunctionNov 30, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
AS REPORTED, WHEN THE CUSTOMER UNPACKED THE PACKAGING, IT WAS IDENTIFIED THAT THE OUTER PACKAGING OF THE PERFIX LIGHT PLUG WAS DAMAGED, WHICH DESTROYED THE STERILE ENVIRONMENT AND COULD NOT BE USED. IT WAS REPORTED THAT THE INNER PACKAGING OF THE MESH PLUG IS NOT SEALED PROPERLY AND DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241042 ↗MalfunctionOct 20, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED ON (B)(6) 2023, THE PATIENT UNDERWENT HIGH LIGATION OF THE RIGHT INGUINAL HERNIA SAC AND TENSION-FREE HERNIA REPAIR UNDER GENERAL ANESTHESIA WITH PERFIX LIGHT PLUG IMPLANT. AFTER THE OPERATION, THE PATIENT HAD SWELLING AND PAIN IN THE SPERMATIC CORD ABOVE THE SCROTUM. IT WAS REPORTED THAT NO ADDITIONAL TREATMENT WAS REQUIRED, AND THE PATIENT¿S STATUS IS REPORTED TO BE GOOD.
Patient problems: Pain; Swelling/ Edema
MAUDE report 17981531 ↗InjuryDec 31, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
AS PER NMPA ((B)(4)): AS REPORTED, THE PATIENT WAS HOSPITALIZED FOR A RIGHT GROIN OBLIQUE AND WAS IMPLANTED WITH A BARD/DAVOL PERFIX LIGHT PLUG ON (B)(6) 2021. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS EXPERIENCED FOREIGN BODY SENSATION AT THE IMPLANTATION SITE BUT THE SURROUNDING SOFT TISSUES HAD NO REDNESS, SWELLING AND PAIN, THE DRESSING OUTSIDE THE INCISION WAS DRY, AND THERE WAS NO BLEEDING OR EXUDATION. IT WAS ALSO REPORTED THE PATIENT CONTINUES POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT.
Patient problems: Discomfort
MAUDE report 13124787 ↗InjuryDec 31, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
AS PER NMPA (CHINA FDA): AS REPORTED, THE PATIENT WAS HOSPITALIZED FOR A RIGHT INDIRECT INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH A BARD/DAVOL PERFIX LIGHT PLUG ON (B)(6) 2021. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT FELT THAT THE FOREIGN BODY SENSATION AT THE PATCH IMPLANTATION SITE AND ALSO THE FLEXION AND MOVEMENT OF THE RIGHT LOWER LIMB WERE AGGRAVATED, THERE WAS NO REDNESS, SWELLING AND PAIN, AND THE EXTERNAL DRESSING OF THE INCISION WAS DRY AND THERE WAS NO EXUDATION. IT WAS ALSO REPORTED THAT THE PATIENT CONTINUES POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT.
Patient problems: Discomfort
MAUDE report 13124785 ↗InjuryNov 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PERFIX PLUG LIGHT. IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF AN INGUINAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION OF THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION AND HERNIA RECURRENCE, NECESSITATING FURTHER REPARATIVE SURGERY WHICH OCCURRED ON (B)(6) 2015. SUBSEQUENT TO THE LATTER SURGERY, THE PATIENT HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTIONS, GASTROINTESTINAL MALFUNCTION AND HERNIA RECURRENCE. IT IS ALLEGED THAT THE PATIENT HAD SUFFERED INJURIES, LOSSES AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. IT IS ALLEGED THAT THE PATIENT TO EXPERIENCE SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALLEGED THAT THE PATIENT HAS BEEN TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, AND REST. IT IS ALSO ALLEGED THAT THE PATIEN
Patient problems: Hernia; Obstruction/Occlusion; Pain
MAUDE report 12730374 ↗MalfunctionOct 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, IT WAS IDENTIFIED THAT AFTER OPENING THE PERFIX LIGHT PLUG PACKAGE ON (B)(6) 2020, A FOREIGN MATERIAL LIKE FILAMENTOUS POLYPROPYLENE WAS FOUND ON THE PLUG. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT DID NOT HAVE INFECTION AT THE TIME OF IMPLANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10753989 ↗InjuryOct 22, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information
ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT A SURGERY FOR THE REPAIR OF LEFT INGUINAL HERNIA AND A BARD/DAVOL PERFIX LIGHT PLUG, EXTRA LARGE WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE DEFECTIVE MESH. IT IS ALLEGED THAT THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, CHRONIC PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, HAS UNDERGONE AND WILL LIKELY REQUIRE MEDICAL TREATMENTS AND OTHER FORMS OF CARE. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE.
Patient problems: Disability; Injury; Pain
MAUDE report 10722266 ↗InjurySep 14, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information
Attorney alleges that the patient underwent surgery for the implant of an unspecified Bard/Davol PerFix Plug on (b)(6) 2014. As reported, the patient is making a claim for an adverse patient outcome against PerFix Plug. Attorney alleges that the patient had subsequent surgical intervention due to the Hernia Mesh device. It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided:(b)(6) 2014 - Patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of PerFix Light Plug. Per operative notes, ¿An incision was made in the left groin. The hernia sac was dissected out. An extra-large PerFix Light Plug was placed into the left inguinal region and secured it with sutures.¿ (b)(6) 2019 - Patient was diagnosed with recurrent incarcerated left inguinal hernia, thereby underwent open repair with primary hernia repair. Per operative notes, ¿An incision was made in the left groin. The hernia sac was dissected out. The defect was closed with sutures primarily.¿ (The previously implanted mesh was not visualized during the procedure.)
Patient problems: Hernia; Injury
MAUDE report 10526630 ↗InjurySep 5, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A PERFIX LIGHT PLUG WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ATTORNEY ALLEGES THE PERFIX LIGHT PLUG WAS DEFECTIVE AT THE TIME OF IMPLANT. ON (B)(6) 2018: THE PATIENT UNDERWENT AN ADDITIONAL OPEN INGUINAL HERNIA REPAIR SURGERY TO REPAIR AND/OR REMOVE THE DEFECTED MESH. ON (B)(6) 2018: THE PATIENT WAS FIRST INFORMED THAT THE PRESENCE OF THE PERFIX LIGHT PLUG IN HER BODY COULD BE THE CAUSE OF HER INJURIES. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.
Patient problems: Disability; Injury; Pain
MAUDE report 8967563 ↗MalfunctionJun 3, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A PIECE OF SMALL PARTICLE WAS ALLEGEDLY SEEN IN STERILE PACKAGING OF A BARD/DAVOL PERFIX LIGHT PLUG. THE PRODUCT WAS NOT OPENED OR USED.
Patient problems: No Patient Involvement
MAUDE report 8663217 ↗InjuryJan 28, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010: THE PATIENT UNDERWENT A LAPAROSCOPIC INCISIONAL HERNIA REPAIR. A BARD/DAVOL PERFIX LIGHT PLUG WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2013: THE PATIENT UNDERWENT REPAIR OF RECURRENT L INDIRECT INGUINAL HERNIA. THE SURGEON NOTED A LARGE PIECE OF MESH FROM PREVIOUS REPAIR WAS SO ADHERENT IN THE TISSUES IT COULD NOT BE REMOVED. THE PATIENT CONTINUES TO SUFFER COMPLICATIONS, PERMANENT DISFIGUREMENT AND CHRONIC PAIN. THE MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE MESH WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.
Patient problems: Deformity/ Disfigurement; Disability; Hernia
MAUDE report 8282643 ↗InjurySep 14, 2018Defective Device; Material Protrusion/Extrusion; Defective Device; Material Protrusion/Extrusion
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016, THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. IT IS ALLEGED THAT A LARGE BARD/DAVOL PERFIX LIGHT PLUG, CAT. NO. 0117080 LOT NO. HUZK0222 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2016, THE UNDERWENT REMOVAL OF THE FAILED PERFIX LIGHT PLUG. THE SURGEON NOTED THAT HE WAS ¿CONCERNED THAT THIS WAS THE MESH PROTRUDING BACKWARDS AND CAUSING HER A GREAT DEAL OF PAIN.¿ IT IS ALLEGED THAT DURING THE SURGERY, THE SURGEON NOTED THAT ¿THERE WAS A VERY FIRM MASS IN THE AREA OF CONCERN THIS WAS CONSISTENT WITH THE PREVIOUS MESH.¿ THE PATIENT CONTINUES TO SUFFER COMPLICATIONS FROM THE BARD/DAVOL PERFIX LIGHT PLUG. IT IS ALLEGED THAT THE BARD/DAVOL PERFIX LIGHT PLUG IS DEFECTIVE. THE PATIENT HAS BEEN INJURED AND SUSTAINED SEVERE PAIN, SUFFERING, DISABILITY, AND IMPAIRMENT.
Patient problems: Disability; Injury; Pain
MAUDE report 7877128 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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