ULTRAPRO UPPL6Recalls & reported problems
Johnson & Johnson International Inc. · Polypropylene partially absorbable large blue / undyed Plug and Onlay Patch · Class 2 · Implant
All models of ULTRAPRO (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031132580), received between Jan 14, 2019 and Aug 8, 2024 — classified as 4 injuries.
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 Problem4
Patient problems
- Pain3
- Fistula1
- Injury1
- Numbness1
- Obstruction/Occlusion1
- Swelling/ Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 RECURRENT LEFT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. THE PATIENT ALSO EXPERIENCE LEFT INGUINAL PAIN AND SWELLING. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 19944184 ↗InjuryMar 23, 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 AN HERNIA REPAIR SURGERY ON (B)(6) 2019 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND NUMBNESS IN ABDOMINAL AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Numbness; Pain
MAUDE report 16595934 ↗InjurySep 16, 2019Adverse 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 INGUINAL HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED CHRONIC PAIN, LEFT INGUINAL HERNIA, URINARY OBSTRUCTION AND FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Fistula; Obstruction/Occlusion; Pain
MAUDE report 9068579 ↗InjuryJan 14, 2019Adverse 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 A HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Injury
MAUDE report 8243218 ↗
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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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