VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD
Report
- Report Number
- 2210968-2024-03810
- Event Type
- Injury
- Date Received
- April 3, 2024
- Date of Event
- August 25, 2023
- Report Date
- April 3, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K032420
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL & VICRYL PLUS SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: PAIN, INFECTION, REDNESS, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL & VICRYL PLUS SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL & VICRYL PLUS SUTURE) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: INT WOUND J.2023;1¿8; DOI: 10.1111/IWJ.14387. NOTE: EVENTS REPORTED ON MW# 2210968-2024-03809, MW# 2210968-2024-03810. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.
TITLE: THE EFFECT OF TRICLOSAN-COATED SUTURES ON THE INCIDENCE OF SURGICAL SITE INFECTION IN LAPAROSCOPIC SLEEVE GASTRECTOMY, LAPAROSCOPIC APPENDICECTOMY OR LAPAROSCOPIC CHOLECYSTECTOMY: A MULTI-CENTRE, DOUBLE-BLIND, RANDOMIZED, INTRA-INDIVIDUAL STUDY THIS STUDY TRIED TO DETERMINE THE EFFICACY OF POLYGLACTIN 910 SUTURE COATED WITH TRICLOSAN IN LOWERING THE PORT SITE INFECTION RATE IN SOME CLEAN-CONTAMINATED WOUND SURGERIES. BETWEEN FEBRUARY 2020 AND FEBRUARY 2023, 480 PATIENTS ELIGIBLE FOR LAPAROSCOPIC CHOLECYSTECTOMY, APPENDICECTOMY OR SLEEVE OPERATIONS WERE INCLUDED IN THE STUDY. THERE WERE 260 MALES AND 220 FEMALES WITH A MEAN AGE OF 42.2 ± 12.2 YEARS (RANGE 18-77) AND A MEAN BMI OF 35.9 ± 9.4 KG/M2 (RANGE 19-60). A STANDARD 3-, 4-, OR 5-PORT TECHNIQUE WAS USED. POLYGLACTIN 910 SUTURES COATED WITH TRICLOSAN (VICRYL PLUS, ETHICON) WERE UTILIZED IN ONE PORT SITE INCISION, WHILE POLYGLACTIN 910 SUTURES (VICRYL, ETHICON) WERE USED IN THE OTHER PORT SITE INCISIONS. THERE WERE 164 PATIENTS SUBJECTED TO APPENDICECTOMY, 232 PATIENTS SUBJECTED TO CHOLECYSTECTOMY, AND 84 PATIENTS SUBJECTED TO SLEEVE GASTRECTOMY. REPORTED COMPLICATIONS INCLUDED PORT SITE PAIN (N= 888 SITES), INFECTION (N=64 SITES), AND REDNESS (N=329 SITES). IN CONCLUSION, THIS STUDY CAN SUPPORT THE BENEFICIAL EFFECTS OF USING TRICLOSAN-COATED POLYGLACTIN SUTURES IN LAPAROSCOPIC OPERATIONS. THE DESIGN OF THIS STUDY (A DOUBLE-BLIND, RANDOMIZED, INTRA-INDIVIDUAL STUDY) AMELIORATES THE SELECTION BIAS AND LIMITS THE VARIABLES THAT MAY AFFECT THE PROCEDURE'S OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1448260 | VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |