VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2025-10085
- Event Type
- Injury
- Date Received
- September 3, 2025
- Date of Event
- July 9, 2024
- Report Date
- September 3, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATIONS: NOT PROVIDED PLEASE SEE ARTICLE ATTACHED.
TITLE: THE EFFECT OF DIFFERENT CRANIAL REPAIR MATERIALS AND SUTURING MATERIALS ON COMPLICATIONS AFTER CRANIOPLASTY. THE AIM OF THIS STUDY IS TO ANALYZE THE EFFECT OF DIFFERENT CRANIAL REPAIR MATERIALS AND SUTURING MATERIALS ON WOUND INFECTION, TITANIUM PLATE EXPOSURE AND EPIDURAL HEMATOMA AFTER CRANIOPLASTY. FROM JANUARY 2013 TO JANUARY 2020, A TOTAL OF 165 PATIENTS WITH SKULL DEFECT REPAIR AMONG THEM, 61 PATIENTS IN THE CONTROL GROUP WERE TREATED WITH COMMON TITANIUM MESH (BIDOIA; SHENZHEN WALD SURGICAL MEDICAL DEVICE TECHNOLOGY CO., LTD.) AND MERSILK SUTURE [ETHICON; JOHNSON & JOHNSON MEDICAL (CHINA) LTD.] TO SUTURE THE CAP APONEUROSIS AND SKIN; 104 PATIENTS IN THE TEST GROUP WERE TREATED WITH THREE DIMENSIONAL RECONSTRUCTION TITANIUM MESH (MANUFACTURER: SHENZHEN SYNTHETIC MEDICAL SYSTEMS CO., LTD.) AND 3-0 VICRYL SUTURE [ETHICON; JOHNSON & JOHNSON MEDICAL (CHINA) LTD.] TO SUTURE THE CAP APONEUROSIS AND SKIN NAIL [KEHUI MEDICAL INTERNATIONAL TRADING (SHANGHAI) CO., LTD.] TO STAPLE THE SKIN. AMONG ALL PATIENTS, THERE WERE 98 MALES AND 67 FEMALES, AGED 22 ~ 69 YEARS, WITH MEAN ONE OF (48.5 PLUS OR MINUS 11.6) YEARS; 31 PATIENTS HAD ARTIFICIAL DAMAGE DURING SEPARATION. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN AGE, SEX, HISTORY OF DIABETES, TIMING OF REPAIR, OR DAMAGE BETWEEN THE TWO GROUPS; THE OPERATION TIME WAS SIGNIFICANTLY LONGER IN THE CONTROL GROUP THAN IN THE EXPERIMENTAL GROUP. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. REPORTED COMPLICATIONS: MERSILK SUTURE (ETHICON): (N=7) CASES OF POSTOPERATIVE INCISION INFECTION IN CONTROL GROUP. TREATMENT: NOT REPORTED. 3-0 VICRYL SUTURE (ETHICON): (N=3) CASES OF POSTOPERATIVE INCISION INFECTION IN TEST GROUP. TREATMENT: NOT REPORTED. IN CONCLUSIONS, THREE-DIMENSIONAL RECONSTRUCTION OF TITANIUM PLATE, COATED VICRYL PLUS ANTIBACTERIAL SUTURE AND SKIN STAPLER CAN REDUCE THE OPERATION TIME AND THE COMPLICATIONS AFTER CRANIOPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1734169 | VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |