PROCEED PCDR1Recalls & reported problems
Johnson & Johnson International Inc. · PROCEED Surgical Mesh 7.5 cm x 15 cm (3" x 6") Rectangular · Class 2 · Implant
All models of PROCEED (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Johnson & Johnson PROCEED surgical mesh is a polymeric mesh used in hernia repair. Most of its 80 adverse event reports describe pain and adhesions after implantation, sometimes with revision or removal surgery, along with inflammation; no deaths, and 80 injuries are reported. No recalls name this device. Reports fell from 9 in the prior 12 months to 3 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10705031047778), received between Jan 9, 2018 and Feb 10, 2026 — classified as 80 injuries.
3 other recalls cover devices cleared under the same FDA submission (K060713); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem79
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain56
- Adhesion(s)39
- Hernia31
- Inflammation29
- Nausea23
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available16
- Diarrhea14
- Chills13
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WOUND INFECTION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Post Operative Wound Infection
MAUDE report 24308039 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LEFT AND RIGHT BILATERAL INGUINAL HERNIA REPAIR ON (B)(6) 2017 AND MESHES WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED GROIN PAIN, SORENESS IN THE TESTICLES AND ABDOMINAL CRAMPING. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Pain
MAUDE report 24074787 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LEFT AND RIGHT BILATERAL INGUINAL HERNIA REPAIR ON (B)(6) 2017 AND MESHES WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED GROIN PAIN, SORENESS IN THE TESTICLES AND ABDOMINAL CRAMPING. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Pain
MAUDE report 24074408 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LEFT LOWER QUADRANT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2020 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22454103 ↗InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22002757 ↗InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21627842 ↗InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21047445 ↗InjuryDec 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCARCERATED INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL VENTRAL HERNIA SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL VENTRAL HERNIA WITH INCARCERATION ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia
MAUDE report 20952203 ↗InjuryDec 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCARCERATED INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL VENTRAL HERNIA SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL VENTRAL HERNIA WITH INCARCERATION ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20952197 ↗InjuryDec 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCARCERATED INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL VENTRAL HERNIA SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL VENTRAL HERNIA WITH INCARCERATION ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia
MAUDE report 20952195 ↗InjuryNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20813615 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT RIGHT INGUINAL HERNIA ON (B)(6) 2011 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THAT THE PREVIOUS MESH APPEARED TO BE WARDED UP. IT WAS REPORTED PATIENT EXPERIENCED CHRONIC RIGHT GROIN AND TESTICULAR PAIN AND NERVE DAMAGE. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2007 AND PROLENE WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Nerve Damage; Pain
MAUDE report 20627242 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HIATAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20158159 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT HERNIA ON 7/27/2010 WITH (2) MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT UNDERWENT OPENING OF INCISION WITH EVACUATION OF INFECTED HEMATOMA WASHOUT OF WOUND AND VAC PLACEMENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, AND WEIGHT LOSS PROBLEM. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Abdominal Pain; Hematoma; Nausea; Unspecified Infection; Weight Changes
MAUDE report 20075993 ↗InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED THE OLD MESH WAS REMOVED IN INCREDIBLE DIFFICULTY AND IT WAS EXTREMELY ADHERENT TO MULTIPLE LOOPS OF SMALL BOWEL. ONE SEROSAL TEAR OF THE SMALL BOWEL WAS REPAIRED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, LOSS OF APPETITE, SCARRING AND DISFIGUREMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Deformity/ Disfigurement; Inflammation; Pain; Scar Tissue
MAUDE report 19939916 ↗InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCARCERATED ABDOMINAL WALL HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED AND HAD ANOTHER REVISION SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SMALL-BOWEL OBSTRUCTION, OBSTIPATION, ADHESIONS, NAUSEA, VOMITING, AND ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.
Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Nausea; Obstruction/Occlusion; Vomiting
MAUDE report 19928816 ↗InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2011 DURING WHICH THE SURGEON NOTED THERE WAS A SIGNIFICANT AMOUNT OF ADHESIONS OF THE SMALL BOWEL TO THE MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS, VOMITING AND HERNIA RECURRENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Hernia; Vomiting
MAUDE report 19919222 ↗InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LAPAROSCOPIC REPAIR SURGERY OF INCARCERATED VENTRAL HERNIA ON (B)(6)2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON(B)(6)2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION CAN BE ADDED.
Patient problems: Insufficient Information
MAUDE report 19640354 ↗InjuryAug 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR ILIOINGUINAL NEURALGIA AND LEFT GROIN PAIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 17467239 ↗InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED HE LYSED THE SMALL BOWEL ADHESIONS TO THE MESH. HE NOTED THE MESH HAD BECOME DETACHED AND REMOVED THE MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, TORN MESH, DISCOMFORT, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT THE PATIENT HAD A MESH IMPLANTED ON (B)(6) 2011 AND UNDERWENT REMOVAL SURGERY AND HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE MESH WAS TORN, WAD DEBRIDED AND REMOVED WHICH ARE CAPTURED IN SEPARATE FILES.
Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Discomfort; Inflammation; Nausea; Pain; Weight Changes
MAUDE report 15778537 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DENSE ADHESIONS. THE OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain
MAUDE report 15499880 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DENSE ADHESIONS. THE OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain
MAUDE report 15499776 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DENSE ADHESIONS. THE OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain
MAUDE report 15499731 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNK DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DENSE ADHESIONS. IT WAS REPORTED THAT THE PATIENT HAD A MESH IMPLANTED ON (B)(6) 2017 AND UNDERWENT REMOVAL SURGERY ON AN UNK DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Adhesion(s); Pain
MAUDE report 15499720 ↗InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15196278 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060713. One submission often covers many models, so check the product and lot details in each record.
- Z-0533-2021 · Oct 23, 2020 · TerminatedPROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
- Z-1329-2014 · Feb 19, 2014 · Open, ClassifiedProceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that r
- Z-0903-2011 · Oct 18, 2010 · Open, ClassifiedPROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the a
Other Mesh, surgical, polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
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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