Parietex TECT1510ADP2RRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521180215), received between Oct 5, 2017 and Jul 16, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE WEEK AFTER A TREATMENT FOR A HERNIA, THE PATIENT HAD PERSISTENT SYMPTOMS SUCH AS SWELLING IN THE RIGHT GROIN, PAIN IN THE INGUINAL FOLD, PAIN IN THE RIGHT TESTICLE AND UPPER BUTTOCK, AND AN INABILITY TO WALK.

  Patient problems: Pain

  MAUDE report 22520201 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ITCHY GROIN RASH, MERALGIA PARAESTHETICA, ABDOMINAL PAIN, PAIN, DISCOMFORT, SWELLING, HERNIA RECURRENCE, AND WEIGHT GAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PAIN MEDICATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Itching Sensation; Pain; Rash; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 20687138 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED WOUND INFECTION, ABSCESS, ABDOMINAL WOUND, ABDOMINAL WALL INFECTION, RECURRENCE, ADHESIONS, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, WOUND INFECTION TREATMENT, ABSCESS/ABDOMINAL WOUND/ABDOMINAL WALL INFECTION DRAINAGE, HERNIA REPAIR.

  Patient problems: Abscess; Adhesion(s); Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15799610 ↗
• InjuryApr 22, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, RECURRENCE, ADHESIONS, HYDROCELE, PERITONEAL FLAP WITH FEW TEARS, SWELLING, FLUID COLLECTIONS, SCARRING, DRAINAGE OF SEROUS FLUID, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TESTICLE REMOVAL, HERNIA REPAIR WITH MESH, REMOVAL OF MESH AND 2 SPIRAL TACKS, MEDICATIONS, AND HYDROCETECTOMY.

  Patient problems: Adhesion(s); Ascites; Discharge; Hernia; Injury; No Code Available; Pain; Scarring; Swelling

  MAUDE report 9986598 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED FISTULA, INFECTION, MESH EROSION INTO COLON, ABSCESS, PURULENT MATERIAL, INADVERTENT BLADDER DEFECT, FIBROTIC TISSUE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC SIGMOID COLECTOMY WITH SPLENIC FLEXURE MOBILIZATION, TAKEDOWN OF COLOCUTANEOUS AND COLOVESICAL FISTULA WITH PRIMARY COLORECTAL ANASTOMOSIS, TAKEDOWN OF SMALL BOWEL TO BLADDER FISTULA (ILEOVESICAL) FISTULA, LYSIS OF ADHESIONS, HERNIA REPAIR, DRAINAGE OF ABSCESS, REMOVAL OF MESH, BLADDER REPAIR WITH PLACEMENT OF SUPRAPUBIC CATHETER, AND SMALL BOWEL RESECTION WITH PRIMARY ILEAL-ILEAL ANASTOMOSIS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9986580 ↗
• InjuryFeb 28, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, ADHESIONS, AND MESH SHIFTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9768910 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA AND AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC ABDOMINAL PAIN, ADHESIONS, FLUID COLLECTION, HEMATOMA, <(>&<)> CONSTIPATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, CAT SCAN, DIAGNOSTIC LAP, LYSIS OF ADHESIONS, <(>&<)> PAIN MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Ascites; Constipation; Distress; Fatigue; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 9294404 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT RIGHT INGUINAL HERNIA, CHRONIC PAIN AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH ETHICON PROLENE MESH, DISSECTED SPERMATIC CORD STRUCTURES OFF CANAL FLOOR AND ILIOINGUINAL NERVE TRANSECTED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Fibrosis; Hernia; Inflammation; Injury; Necrosis; Nerve Damage; No Code Available; Nodule; Numbness; Pain; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 8491128 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SCARRING, INFLAMMATION AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION AND HYDROCELECTOMY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Constipation; Discomfort; Emotional Changes; Erosion; Fistula; Hernia; Inflammation; Injury; Necrosis; No Code Available; Pain; Scar Tissue; Scarring; Seroma; Swelling; Unspecified Tissue Injury

  MAUDE report 8442096 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, AND A SYMPTOMATIC RIGHT SPERMATOCELE (SPERMATIC CYST). TREATMENT INCLUDED A SPERMATOCELECTOMY AND SURGICAL REVISION OF THE MESH.

  Patient problems: Adhesion(s); Cyst(s); Injury

  MAUDE report 7799807 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED HERNIA RECURRENCE AND ADDITIONAL SURGERY. TREATMENT AND POTENTIALLY RELATED PROCEDURES INCLUDE ADDITIONAL SURGICAL PROCEDURE.

  Patient problems: Hernia; Injury; No Code Available

  MAUDE report 7636238 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER A HERNIA PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED MILDLY ENLARGED MESENTERIC LYMPH NODE, ACHES, PAINS, RANDOM BOUTS OF FEVER, HIGH BLOOD PRESSURE (FOR THE FIRST TIME IN HIS LIFE), AN UNEXPLAINED NERVE/BURNING PAINS IN HIS TESTICLES AND GROIN, AND A SHARPLY DIMINISHED LIBIDO. PLAINTIFF HAS, SINCE EARLY 2018, LOST 10-15 POUNDS FOR NO APPARENT REASON AND HAS A DECREASED APPETITE. PLAINTIFF HAS ALSO EXPERIENCED BACK PAIN AND FATIGUE. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED, INCLUDING REVISION.

  Patient problems: Fatigue; Fever; Injury; No Code Available; Pain

  MAUDE report 7511836 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF RECURRENT RIGHT INGUINAL HERNIA IN A LAPAROSCOPIC REPAIR. THE PATIENT EXPERIENCED PAIN, FISTULA, FIBROSIS, PURULENT MATERIAL, ADHESIONS, SCARRING, INFLAMMATION AND INFECTION. POST-OPERATIVE TREATMENT INCLUDED SURGICAL REVISION, PURULENT MATERIAL DRAINED, LAPAROSCOPIC EXCISION OF INFECTED MESH, RIGHT INGUINAL HERNIA MESH INCISION OF RIGHT GROIN WITH EXPLORATION AND DRAINAGE OF SOFT TISSUE DEEP ABSCESS.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fibrosis; Fistula; Fluid Discharge; Hernia; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Scar Tissue; Scarring; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 6915517 ↗