Strattice Reconstructive Tissue MatrixRecalls & reported problems across all models

We found 17 models of Strattice Reconstructive Tissue Matrix by Lifecell Corporation in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Apr 16, 2018 and Feb 16, 2026 — classified as 183 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Strattice Reconstructive Tissue Matrix problems

Strattice Reconstructive Tissue Matrix models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Strattice Reconstructive Tissue Matrix 1016002

  Mesh, Surgical
  40 reports
• Strattice Reconstructive Tissue Matrix 1620002

  Mesh, Surgical
  37 reports
• Strattice Reconstructive Tissue Matrix 2025002

  Mesh, Surgical
  23 reports
• Strattice Reconstructive Tissue Matrix 1010002

  Mesh, Surgical
  18 reports
• Strattice Reconstructive Tissue Matrix 2020002

  Mesh, Surgical
  12 reports
• Strattice Reconstructive Tissue Matrix 2030002

  Mesh, Surgical
  10 reports
• Strattice Reconstructive Tissue Matrix 2540002

  Mesh, Surgical
  7 reports
• Strattice Reconstructive Tissue Matrix 0608001

  Mesh, Surgical
  6 reports
• Strattice Reconstructive Tissue Matrix 0610008

  Mesh, Surgical
  6 reports
• Strattice Reconstructive Tissue Matrix 3030002

  Mesh, Surgical
  6 reports
• Strattice Reconstructive Tissue Matrix 0616002

  Mesh, Surgical
  5 reports
• Strattice Reconstructive Tissue Matrix 0808002

  Mesh, Surgical
  4 reports
• Strattice Reconstructive Tissue Matrix 2040002

  Mesh, Surgical
  3 reports
• Strattice Reconstructive Tissue Matrix 1020002

  Mesh, Surgical
  2 reports
• Strattice Reconstructive Tissue Matrix 1025002

  Mesh, Surgical
  2 reports
• Strattice Reconstructive Tissue Matrix 0816001

  Mesh, Surgical
  1 report
• Strattice Reconstructive Tissue Matrix 1525002

  Mesh, Surgical
  1 report

Recent Strattice Reconstructive Tissue Matrix adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 10/MAR/2026, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED.AS PER THE PPF FORM, THE PATIENT UNDERWENT A RECURRENT VENTRAL HERNIA SURGERY WITH A STRATTICE DEVICE LOT #SP100273-220, REF. #1016002P ON (B)(6) 2015. ON (B)(6) 2023, PATIENT UNDERWENT ROBOTIC LYSIS OF ADHESIONS AND EXCISION OF PREVIOUSLY PLACED MESH. ROBOTIC ASSISTED LAPAROSCOPIC RECURRENT VENTRAL HERNIA REPAIR WITH MESH. THE AFFECTED STRATTICE WAS REMOVED AND REPLACED WITH A NON-ABBVIE DEVICE, BARD VENTRALIGHT ST, LOT NUMBER HUGY0866. AS PER THE PPF FORM, THE PATIENT CLAIMS "CONTRACTED AND ROLLED MESH; DENSE ADHESIONS TO BOWEL WITH 90 MINUTES LYSIS; RECURRENCE." AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2015. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 24349588 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 17/NOV/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. THIS RECORD CAPTURES THE 3RD STRATTICE DEVICE. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH STRATTICE DEVICES LOTS ¿SP200471-041,¿ ¿SP200503-106,¿ AND ¿SP200531-007¿ ON (B)(6) 2023. THE PATIENT UNDERWENT A ¿REPAIR OF RECURRENT DEFECT DUE TO NON ADHERENCE OF PRIOR MESH, REMOVAL OF OLD STRETCHED MESH¿ ON (B)(6) 2024 AND REPLACED WITH A NON-ABBVIE DEVICE, ¿BARD PHASIX ST - REF: (B)(4). THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿LONG INFECTION, ABSCESS, EXTENSIVE HOSPITALIZATION, SEROMA, PAIN¿ BETWEEN (B)(6) 2023 AND (B)(6) 2025. THE PATIENT WAS THEN TREATED FOR ¿MRSA INFECTION¿ BETWEEN (B)(6) 2023. THE PATIENT RECEIVED TREATMENT FOR ¿INFECTION, PAIN, FEVER, ABDOMINAL WALL FLUID COLLECTION¿ BETWEEN (B)(6) 2023. THE PATIENT RECEIVED ¿PAIN MANAGEMENT¿ FROM 2024-2025. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, ¿BARD PHASIX ST - REF: (B)(4),¿ ON (B)(6) 2024. THE FORM DOES NOT INDICATE WHETHER THIS DEVICE WAS REMOVED OR REVISED. THE PLAINTIFF ALSO SOUGHT TREATMEN

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Post Operative Wound Infection; Seroma

  MAUDE report 23658966 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14/AUG/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH TWO STRATTICE DEVICES ON (B)(6) 2018. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS, DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT UNDERWENT AN ¿ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT A ¿NON-HEALING SUTURE ABSCESS, SUTURE REMOVAL, ABSCESS CAVITY DEBRIDED¿ ON (B)(6) 2021. THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿OPEN INCISIONAL HERNIA REPAIR (2-LAYER SANDWICH MESH REPAIR WITH STRATTICE AND A PRIMARY FASCIA CLOSURE); ABSCESS CAVITY DEBRIDED¿ BETWEEN (B)(6) 2018 AND (B)(6) 2018. THE PATIENT WAS THEN TREATED FOR ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS; DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT RECEIVED TREATMENT FOR ¿ABDOMINAL WALL PAIN; ABDOMINAL WALL ABSCESS; ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON OR ABOUT (B)(6) 2021. THE PATIENT RECEIVED ¿INCISION & DRAINAGE; CHRONIC ABDOMINAL WOUND INFECTION; SUTURE ABSCESS (SUTURE CUT);

  Patient problems: Abscess; Cellulitis; Post Operative Wound Infection

  MAUDE report 22916210 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE AND 2ND STRATTICE FIRM ON (B)(6) 2023. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (EMDR- (B)(4) ). THIS EMDR IS BEING SUBMITTED FOR THE 2ND STRATTICE FIRM.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Post Operative Wound Infection; Seroma

  MAUDE report 22903559 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE AND 2ND STRATTICE FIRM ON (B)(6) 2023. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) ((B)(4)). THIS EMDR IS BEING SUBMITTED FOR THE 1ST STRATTICE.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Post Operative Wound Infection; Seroma

  MAUDE report 22903543 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11/AUG/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE ON (B)(6) 2020. THE PATIENT UNDERWENT A ¿REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH¿ ON (B)(6) 2022. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED THE FOLLOWING INJURIES: ¿PHYSICAL INJURY, LOSS OF ENJOYMENT OF LIFE, AND ECONOMIC AND NON-ECONOMIC LOSSES AS A RESULT OF [THEIR] STRATTICE IMPLANT. [THE PLAINTIFF] IS DEPENDENT ON OTHERS TO HELP WITH TASKS [THEY HAVE] DIFFICULTY COMPLETING [THEMSELVES.] THESE INJURIES CONTRIBUTE TO [THE PLAINTIFF¿S] ANXIETY AND DEPRESSION.¿ THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿EXTENSIVE LYSIS OF ADHESIONS, SMALL BOWEL RESECTIONS X3, PARTIAL TRANSVERSE COLECTOMY, GASTROJEJUNOSTOMY BILLROTH II, EXCISION OF ABDOMINAL WALL SCAR AND INFECTED MESH, ABDOMINAL RECONSTRUCTION WITH COMPONENT SEPARATION CREATING SKIN FLAPS, CARE OF AN INCISIONAL HERNIA WITH STRATUS MESH; ENTEROCUTANEOUS FISTULA¿ BETWEEN (B)(6) 2020. THE PATIENT WAS THEN TREATED FOR ¿NAUSEA, VOMITI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 21620933 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP #1 TO REPORT ON 27/AUG/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT A RECURRENT INCARCERATED INCISIONAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT #S10832-147, REF. # (B)(4) ON (B)(6) 2010. CAPTURING CATALOG NUMBER AS 1620002. ON (B)(6), PATIENT UNDERWENT A REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT #S10705-031, REF. #(B)(4). PATIENT ALSO UNDERWENT A REMOVAL OF PREVIOUS ABDOMINAL WALL MESH PROCEDURE AND LYSIS OF ADHESIONS. ON (B)(6) 2019, PATIENT UNDERWENT OPEN RIVES-STOPPA VENTRAL HERNIA REPAIR WITH TRANSVERSUS ABDOMINIS RELEASE (TAR), MESH EXCISION AND SKIN FLAP CREATION. THE FORM LISTS THE CONDITION THAT WAS TREATED: FROM 2009 THROUGH 2012, HERNIA SYMPTOMS, HERNIA SURGERIES, POST-OP FOLLOW-UPS. (B)(6) 2010 - DRAINAGE OF INTRA-ABDOMINAL, ABSCESS, LYSIS OF ADHESIONS, REMOVAL OF PREVIOUS ABDOMINAL WALL MESH, REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH (1ST STRATTICE IMPLANT). (B)(6) 2010 - DRAIN SITE INFECTION. (B)(6) 2010 - REPAIR OF RECURRENT INCARCERATED INCISI

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion; Post Operative Wound Infection

  MAUDE report 21620921 ↗
• InjuryMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THIS IS FOLLOW UP#1 TO REPORT ON 14/AUG/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH TWO STRATTICE DEVICES ON (B)(6) 2018. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS, DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT UNDERWENT AN ¿ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT A ¿NON-HEALING SUTURE ABSCESS, SUTURE REMOVAL, ABSCESS CAVITY DEBRIDED¿ ON (B)(6) 2021. THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿OPEN INCISIONAL HERNIA REPAIR (2-LAYER SANDWICH MESH REPAIR WITH STRATTICE AND A PRIMARY FASCIA CLOSURE); ABSCESS CAVITY DEBRIDED¿ BETWEEN (B)(6) 2018. THE PATIENT WAS THEN TREATED FOR ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS; DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT RECEIVED TREATMENT FOR ¿ABDOMINAL WALL PAIN; ABDOMINAL WALL ABSCESS; ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON OR ABOUT (B)(6) 2021. THE PATIENT RECEIVED ¿INCISION & DRAINAGE; CHRONIC ABDOMINAL WOUND INFECTION; SUTURE ABSCESS

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Post Operative Wound Infection

  MAUDE report 21612584 ↗
• InjuryMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE FIRM ON (B)(6) 2012. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Post Operative Wound Infection

  MAUDE report 21610507 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 28/MAR/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF). AS PER THE PPF FORM, THE PATIENT UNDERWENT RECURRENT INCARCERATED INCISIONAL HERNIA SURGERY AND WAS IMPLANTED WITH THE STRATTICE DEVICE LOT# SP100392-141 AND REF. #(B)(4) ON (B)(6) 2016. ON (B)(6) 2018, PATIENT UNDERWENT SMALL-BOWEL RESECTION, PRIMARY ANASTOMOSIS, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF PRIOR MESH AND REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH A NON-ABBIVE DEVICE, PHASIX MESH (LOT #HUBY1146). THE FORM LISTS THE CONDITION THAT WAS TREATED: (B)(6) 2016 - REDUCTION AND REPAIR (STRATTICE) OF INCISIONAL HERNIA WITH SMALL BOWEL REPAIR AND EXTENSIVE LYSIS OF ADHESIONS. (B)(6) 2018 - ABDOMINAL PAIN, EVALUATION OF SBO; CT AB/PEL SCAN-SMALL BOWEL OBSTRUCTION SECONDARY TO VENTRAL HERNIA CONTAINING BOTH SMALL AND LARGE BOWEL. (B)(6) 2018 - ABDOMINAL PAIN; SMALL-BOWEL RESECTION, PRIMARY ANASTOMOSIS, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF PRIOR MESH AND PHASIX MESH REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. ON (B)(6) 2014, PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, VENTRALIGHT ST, LOT #HUYB0394. ON (B)(6) 2016, VENTRALIGHT ST ME

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion

  MAUDE report 21345558 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP #1 TO REPORT ON 18/FEB/2024, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF). AS PER THE PPF FORM, THE PATIENT UNDERWENT A REPAIR OF RECURRENT HIATAL HERNIA WITH A REDUCTION OF INTRATHORACIC OMENTUM AND GASTRIC SLEEVE; DIAPHRAGMATIC CRURAL REPAIR REINFORCEDAND AND PATIENT WAS IMPLANTED WITH THE STRATTICE DEVICE LOT# SP100311-133; REF. # 0608001 ON (B)(6) 2016. ON (B)(6) 2016, PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA WITH PRIMARY CLOSURE AND IMPLANTED WITH A NON-ABBVIE DEVICE, ONLAY PHASIX MESH (BARD PHASIX MESH LOT #HUAT2166). ON (B)(6) 2016, A SUBCUTANEOUS SEROMA WAS DRAINED AND SEROSANGUINEOUS FLUID ASPIRATED. THE FORM LISTS THE CONDITION THAT WAS TREATED: ON (B)(6) 2017, AN EXPLORATORY LAPAROTOMY AND SEGMENTAL SMALL BOWEL RESECTION. APPROX. 2016-2017, CAT SCANS OF AB/PEL AND MRI DIAGNOSTIC TESTING PERFORMED. RESULT WAS NOT PROVIDED. BETWEEN (B)(6) 2017, EXPLORATORY LAPAROTOMY AND SEGMENTAL SMALL BOWEL RESECTION PERFORMED. ON (B)(6) 2017, PRESSED FLUID OUT OF SEROMA IN OFFICE POST-OPERATIVELY. BETWEEN (B)(6) 2015 - 2016, FOLLOW UP ON HERNIA SURGERIES REPAIR AND SYMPTOMS. ON (B)(6) 2017, EXPRESSED FLUID (SEROMA FROM BOWEL OBSTRUCTIO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 21343865 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE FIRM ON (B)(6) 2019. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 21267332 ↗
• InjuryDec 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE MESH ON (B)(60 2015 AND 2ND STRATTICE MESH ON (B)(6) 2021. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. THIS IS THE PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6),(EMDR (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE 2ND STRATTICE MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 20971971 ↗
• InjuryDec 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE MESH ON (B)(6) 2015 AND 2ND STRATTICE MESH ON (B)(6) 2021. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. THIS IS THE PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6), (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE 1ST STRATTICE MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion

  MAUDE report 20971860 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2018. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20001808 ↗

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