PRINEO
Received Jul 30, 2026 · Event occurred Jan 1, 2026
Report 2210968-2026-07607 · MDR key 50081442
Device
Generic name
Surgical Sealant
Manufacturer
Ethicon Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Fluid Discharge
- Insufficient Information
Narrative
Description of Event or Problem
This report is being filed after the review of a clinical evaluation report (CER) from a related research activity database (DRRA) for patients undergoing unknown procedure. The reported complication as per ICD 9 & 10 categorization experienced by the following with corresponding intervention: Clinical and Economic Impact of Advanced skin closure in ERAS TJA patients in Australia.Outcome DescriptionWound ooze in THA RulesYes/No during index hospitalizationCount 0 Outcome DescriptionReadmission in THA Rules30 days readmission to same facility within 30 days, all causeCount 2 Outcome DescriptionRe-surgery in THA Rules180 days re-surgery to same facility within 180 days, all cause Count 2Outcome DescriptionWound ooze in TKARules Yes/No during index hospitalization Count5Outcome DescriptionReadmission in TKA Rules30 days readmission to same facility within 30 days, all cause Count 13Outcome DescriptionRe-surgery in TKA Rules180 days re-surgery to same facility within 180 days, all causeCount 5
Additional Manufacturer Narrative
PRODUCT COMPLAINT # ==> PC-002211279This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Ethicon Inc, or its employees that the report constitutes an admission that the product, Ethicon Inc, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This report is related to a clinical evaluation report; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.The single complaint was reported with multiple events. There are no additional details regarding the additional events.