PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2024-12036
- Event Type
- Injury
- Date Received
- November 14, 2024
- Date of Event
- April 18, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- N18331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). THIS 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE AMERICAN JOURNAL OF SURGERY. PAGES: 233-238. HTTPS://DOI.ORG/10.1016/J.AMJSURG.2023.04.013.
TITLE : THE UTILIZATION OF AN ABSORBABLE MESH AFTER OSTOMY REVERSAL DOES NOT DECREASE INCISIONAL HERNIA RATES THE AIM OF THIS STUDY WAS TO INVESTIGATE IF THE USE OF AN ABSORBABLE MESH IN PATIENTS UNDERGOING STOMA REVERSAL DECREASES THE INCIDENCE OF INCISIONAL HERNIAS POSTOPERATIVELY. A TOTAL OF 303 PATIENTS UNDERWENT OSTOMY REVERSAL DURING THE STUDY PERIOD AND 215 PATIENTS MET INCLUSION CRITERIA. THE CONTROL GROUP CONSISTED OF 148 PATIENTS WHO WERE REVERSED WITHOUT MESH REINFORCEMENT. SIXTY-SEVEN PATIENTS RECEIVED MESH REINFORCEMENT AND WERE INCLUDED IN THE INTERVENTIONAL GROUP. IN THE MESH GROUP, EITHER A BIOPROSTHETIC MESH OR A BIOLOGICAL MESH WAS PLACED. MESH WAS PLACED EITHER IN A SUBLAY/RETRO-RECTUS/RETROMUSCULAR FASHION OR IN AN ONLAY FASHION. THE FASCIA WAS CLOSED USING POLYDIAOXANE SUTURE (ETHICON PDS #1) IN EITHER A RUNNING OR INTERRUPTED FASHION. IN THE CONTROL GROUP, THE FASCIA WAS CLOSED USING POLYDIAOXANE SUTURE (ETHICON PDS #1) IN EITHER A RUNNING OR INTERRUPTED FASHION. THE REPORTED COMPLICATIONS INCLUDED INFECTION ; SUPERFICIAL AND DEEP (N=13) AND HERNIA RECURRENCE (N=28). IN CONCLUSION, PROPHYLACTIC USE OF AN ABSORBABLE BIOSYNTHETIC MESH DID NOT ALTER THE RATE OF INCISIONAL HERNIA RATES FOLLOWING OSTOMY REVERSAL IN OUR COHORT OF PATIENTS. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE OVERALL MESH COMPLICATIONS RATES INCLUDING SSO/SSI BETWEEN THE TWO GROUPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1195819 | PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |