VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2025-09841
- Event Type
- Injury
- Date Received
- August 27, 2025
- Report Date
- August 29, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.
PRODUCT COMPLAINT #(B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.
TITLE: ANALYSIS OF THE EFFECT OF SUPERTENSIONREDUCING SUTURE TECHNOLOGY IN CLINICAL APPLICATIONS. THE AIM OF THIS STUDY WAS TO EXPLORE THE APPLICATION EFFECT OF HYPERTENSION SUTURE TECHNOLOGY IN CLINICAL PRACTICE AND THE ANALYSIS AND TREATMENT OF THE CAUSES OF RELATED COMPLICATIONS. BETWEEN JANUARY 2022 TO MARCH 2023, A TOTAL OF 162 PATIENTS WERE INCLUDED IN THIS GROUP. THERE WERE 94 MALES AND 68 FEMALES, AGED 1-70 YEARS, WITH MEAN ONE OF 24.8 YEARS. AMONG THEM, THERE WERE 95 CASES ON THE FACE, 8 CASES ON THE CHEST WALL, 26 CASES ON THE ABDOMINAL WALL, 23 CASES ON BOTH UPPER LIMBS, 4 CASES ON THE LOWER LIMBS, AND 6 CASES ON THE BACK. TREATED WITH PDS-II SIZE 0 AND PDS-II SIZE 4-0 ABSORBABLE SUTURES (JOHNSON & JOHNSON, USA) WERE USED FOR DEEP FASCIA LAYER OR SUPERFICIAL FASCIA LAYER HYPERTENSION-RELIEVING SUTURE, PDS-II SIZE 4-0 AND 5-0 THE EPIDERMAL LAYER 6-0/7-0 NYLON SUTURE WAS USED FOR INTERRUPTED EPIDERMAL SUTURE. IF THE WOUND MARGIN IS SHALLOW AND THE TISSUE TENSION IS RELATIVELY SMALL, USE PDS-II 4-0 OR 5-0 SUTURE OR 5-0 VICRYL SUTURE (JOHNSON & JOHNSON, USA), THE NEEDLE WAS INSERTED 0.5 ~ 2.0 CM AWAY FROM THE WOUND EDGE, ABSORBABLE SUTURES WERE USED FOR THE SECOND HYPERTENSION-RELIEVING SUTURE NEAR THE DEEP DERMIS ABOUT 1.0 ~ 2.0 CM AWAY FROM THE WOUND EDGE. THE DEEP DERMIS WAS HOOKED AT THIS SITE, THE SKIN LAYER WAS GIVEN INTERRUPTED SUTURE WITH NO. 6-0 OR 7-0 NYLON SUTURE (SHANDONG WEIGAO GROUP, WEIHAI FROM UNKNOWN MANUFACTURER) OR INTRADERMAL SUTURE WITH NO. 6-0 NON-ABSORBABLE SUTURE (JOHNSON & JOHNSON, USA). THE FOLLOW-UP WAS CARRIED OUT IN 3, 6 AND 12 MONTHS TO EVALUATE THE POSTOPERATIVE EFFECTS AND COMPLICATIONS. REPORTED COMPLICATIONS: PDS-II SUTURE (SIZE 0, SIZE 4-0, AND 5-0; ETHICON) 5-0 VICRYL SUTURE (ETHICON). HAD SLIGHT REDNESS IN THE OPERATION AREA WITH A HISTORY OF ALLERGY TO MULTIPLE ANTIBIOTICS (N=1). TREATMENT: DISCHARGED THE SURGICAL SUTURE TIP 1 MONTH AFTER THE OPERATION BUT DURING FOLLOW-UP 6 MONTHS LATER, THE SCAR IN THE OPERATION AREA WAS MORE OBVIOUS. THE WHITE SUTURE TIP IN THE OPERATION AREA OCCURRED ABOUT 3 WEEKS AFTER THE OPERATION WHO HAD NO CLEAR HISTORY OF ALLERGY, CONSIDERING THAT THE SUBCUTANEOUS SUTURE IN THE OPERATION AREA WAS TOO SHALLOW (N=2). TREATMENT: WAS TIMELY REMOVED BUT DURING FOLLOW-UP 6 MONTHS AFTER THE OPERATION, THE SCAR WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING OPERATION AREA. FAT LIQUEFACTION OCCURRED IN THE OPERATION AREA (N=2; 1 EAR RECONSTRUCTION CHEST WALL COSTAL CARTILAGE OPERATION AREA, ABOUT 12.8 CM × 3.5 CM IN SIZE, 1 BURN PATIENT ABDOMINAL WALL SKIN OPERATION AREA, ABOUT 10.8 CM × 4.2 CM IN SIZE) TREATMENT: HEALED BY FIRST INTENTION AFTER ACTIVE TREATMENT BUT THE SCAR IN THE SURGICAL AREA WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING SURGICAL AREA DURING THE FOLLOW-UP AT 6 MONTHS AFTER OPERATION. BLISTER (N=2) TREATMENT: HEALED BY FIRST INTENTION AFTER PUNCTURE ASPIRATION AND OTHER SYMPTOMATIC TREATMENT BUT THE LONG-TERM SCAR WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING SURGICAL AREA. BLOOD BLISTER (N=1) TREATMENT: HEALED BY FIRST INTENTION AFTER PUNCTURE ASPIRATION AND OTHER SYMPTOMATIC TREATMENT BUT THE LONG-TERM SCAR WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING SURGICAL AREA. 6-0 NON-ABSORBABLE SUTURE (ETHICON) FAT LIQUEFACTION OCCURRED IN THE OPERATION AREA (N=?; 1 EAR RECONSTRUCTION CHEST WALL COSTAL CARTILAGE OPERATION AREA, ABOUT 12.8 CM × 3.5 CM IN SIZE, 1 BURN PATIENT ABDOMINAL WALL SKIN OPERATION AREA, ABOUT 10.8 CM × 4.2 CM IN SIZE) TREATMENT: HEALED BY FIRST INTENTION AFTER ACTIVE TREATMENT BUT THE SCAR IN THE SURGICAL AREA WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING SURGICAL AREA DURING THE FOLLOW-UP AT 6 MONTHS AFTER OPERATION. BLISTER (N=?) TREATMENT: HEALED BY FIRST INTENTION AFTER PUNCTURE ASPIRATION AND OTHER SYMPTOMATIC TREATMENT BUT THE LONG-TERM SCAR WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING SURGICAL AREA. BLOOD BLISTER (N=?) TREATMENT: HEALED BY FIRST INTENTION AFTER PUNCTURE ASPIRATION AND OTHER SYMPTOMATIC TREATMENT BUT THE LONG-TERM SCAR WAS SLIGHTLY MORE OBVIOUS THAN THAT IN THE SURROUNDING SURGICAL AREA. IN CONCLUSIONS, OVERREDUCTIVE SUTURE SURGERY IS DEFINITIVE BUT SHOULD BE USED APPROPRIATELY TO REDUCE ASSOCIATED COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1498727 | VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |