MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2024-03777
- Event Type
- Injury
- Date Received
- April 2, 2024
- Date of Event
- June 16, 2022
- Report Date
- April 2, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAN
- PMA / PMN Number
- K960653
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (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. ATTEMPTS ARE BEING 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? 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. RELATED EVENTS CAPTURED VIA 2210968-2024-03778. CITATIONS : INTERNATIONAL UROGYNECOLOGY JOURNAL.34:297¿300 HTTPS://DOI.ORG/10.1007/S00192-022-05216-3.
TITLE : DOUBLE-LAYERED ANTERIOR COLPORRHAPHY (DAC)¿VIDEO AND MID-TERM FOLLOW-UP OF 60 PATIENTS. THE AIM OF THIS WORK WAS TO INVESTIGATE THE OUTCOME AFTER DAC AND TO GIVE A DETAILED DESCRIPTION OF THE PROCEDURE. A HIGH ANATOMICAL CURE RATE, FREQUENT RESOLUTION OF PVR AND HIGH PATIENT SATISFACTION WERE OBSERVED. THE RETROSPECTIVE STUDY INCLUDED WOMEN (N=101) TREATED BY DAC WITH VAGINAL HYSTERECTOMY AND APICAL FXATION BETWEEN JANUARY 2018 AND AUGUST 2019. THE KEY DIFFERENCE BETWEEN DAC AND AC IS THE FOLLOWING UNLOCKED CONTINUOUS SUTURE [ETHICON® COATED VICRYL¿ (POLYGLACTIN 910), BRAIDED ABSORBABLE SUTURE 0]. STARTING WITH A SUTURE (COATED VICRYL¿, 0) AT THE VESICOUTERINE LIGAMENTS, THE FASCIA IS TAKEN AS LATERALLY AS POSSIBLE AND PLACATED BY INTERRUPTED HORIZONTALLY ORIENTED SUTURES WITH A DISTANCE OF 0.5¿1.0 CM BETWEEN SUTURES. THE COLPOTOMY IS CLOSED WITHOUT TENSION WITH A LOCKED CONTINUOUS SUTURE [ETHICON® MONOCRYL¿ (POLIGLECAPRONE 25), MONOFLAMENT ABSORBABLE SUTURE 3-0]; THE EPITHELIUM OF THE VAGINAL VAULT IS CLOSED WITH 2¿4 INTERRUPTED SUTURES (COATED VICRYL¿, 0). THE REPORTED COMPLICATIONS INCLUDED RECURRENT CYSTOCELE (N=11), PELVIC ORGAN PROLAPSE QUANTIFICATION (N=5), AND POSTVOID RESIDUAL URINE(N=5). IN CONCLUSION, WE OBSERVED HIGH ANATOMIC CURE RATE AND SATISFACTION AFTER DAC. WITH DESCRIPTION AND VIDEO OF THE TECHNIQUE, IT IS REPRODUCIBLE AND COMPARABLE TO OTHER METHODS. RANDOMIZED CONTROLLED TRIALS SHOULD FOLLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1821111 | MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT | SUTURE, ABSORBABLE, SYNTHETIC | GAN | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |