VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2024-01514
- Event Type
- Injury
- Date Received
- February 16, 2024
- Date of Event
- May 23, 2022
- Report Date
- February 16, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. 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 2210968-2024-01514 AND 2210968-2024-01515. CITATION: FRONT. PEDIATR. MAY 2022; 10:890156. HTTPS://DOI.ORG/10.3389/FPED.2022.890156.
TITLE: TREATED PIERRE ROBIN SEQUENCE USING PLACED ALLOGENIC ACELLULAR BONE MATRIX AND MANDIBULAR DISTRACTION OSTEOGENESIS IN THE NEONATE. THE AIM OF THE STUDY WAS TO REPORT OUR EXPERIENCE WITH PLACED ALLOGENIC ACELLULAR BONE MATRIX AND MANDIBULAR DISTRACTION OSTEOGENESIS IN PIERRE ROBIN SEQUENCE (PRS), AND EXPLORE THE ROLE OF DISTRACTION IN THE OSTEOGENESIS OF ACELLULAR BONE. A TOTAL OF 428 NEONATES WITH SEVERE PRS MANAGED WITH PLACING ALLOGENIC ACELLULAR BONE AND BILATERAL MANDIBULAR DISTRACTION OSTEOGENESIS FROM JANUARY 2011 TO JANUARY 2021, WERE INCLUDED IN THE STUDY. A POLYGLACTIN 4-0 (VICRYL; ETHICON INC) SUTURE WAS USED FOR RECONSTRUCTION OF THE PTERYGOMASSETERIC SLING. THE DERMIS WAS SUTURED APPROXIMATELY WITH A POLYGLACTIN 6-0 (VICRYL; ETHICON INC), AND SKIN WAS CLOSED WITH 7-0 POLYPROPYLENE (PROLENE; ETHICON INC) SUTURE. AFTER 2 WEEKS OF THE SURGERY, STITCHES WERE TAKEN OFF. REPORTED COMPLICATIONS INCLUDE SURGICAL-SITE INFECTION OCCURRED 1 MONTH AFTER DISCHARGE (N=?). IN CONCLUSION, BILATERAL MANDIBULAR DISTRACTION OSTEOGENESIS COMBINED WITH PLACING ALLOGENIC ACELLULAR BONE IN THE NEONATE ARE SAFE AND ACCURATE PROCEDURES, WHICH ARE THE PRIMARY TREATMENT OPTIONS FOR CASES OF SEVERE PRS. IT CAN BE CONSIDERED THAT THE TENSION OF DISTRACTION CAN PROMOTE OSTEOGENESIS IN ACELLULAR BONE AND THUS IMPROVE DISTRACTIVE EFFECT OF THE MANDIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416364 | VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |