PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2026-00983
- Event Type
- Injury
- Date Received
- January 27, 2026
- Date of Event
- January 1, 2025
- Report Date
- January 27, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: CLIN MED INSIGHTS CASE REP. 2025 SEP 1;18:11795476251370546. HTTPS://DOI.ORG/10.1177/11795476251370546 PMID: 40904907; PMCID: PMC12402591.
TITLE: BEYOND SUTURES: MOIST EXPOSED BURN OINTMENT (MEBO) AND SCAR MASSAGE FOR ANATOMICAL RESTORATION OF PENETRATING UPPER LIP LACERATION AT THE VERMILION-CUTANEOUS JUNCTION IN PRIMARY CARE-A CASE REPORT. THIS IS A CASE STUDY OF A 19-YEAR-OLD MALE CONSTRUCTION WORKER SUSTAINED A FULL-THICKNESS LACERATION FROM THE VERMILION CUTANEOUS JUNCTION TO THE INNER MUCOSA. THE INJURY WAS REPAIRED IN A PRIMARY CARE CLINIC, WHERE PRECISE VERMILION ALIGNMENT WAS ESSENTIAL. LAYERED CLOSURE WAS PERFORMED USING ABSORBABLE (5-0 VICRYL) SUTURES FOR MUCOSAL, MUSCULAR, AND DERMAL LAYERS, AND NONABSORBABLE (6-0 PROLENE) SUTURES FOR THE VERMILION-CUTANEOUS JUNCTION. REPORTED COMPLICATIONS ARE N=1; 19-YEAR-OLD MALE -MINIMAL SCARRING TREATMENT: NOT MENTIONED. -AT THE 5-DAY FOLLOW-UP, MODERATE SWELLING WAS NOTED ON THE LEFT SIDE OF THE UPPER LIP TREATMENT: ELEVATE HIS HEAD WHILE LYING DOWN, USING 2 TO 3 PILLOWS TO REDUCE BLOOD FLOW TO THE AREA, PROMOTE HEALING, AND MINIMIZE SWELLING AND ANTI-INFLAMMATORY DRUG (REPARIL 20MG) -DURING THE 6-WEEK FOLLOW-UP VISIT, ONLY MINIMAL SWELLING WAS NOTED TREATMENT: NOT MENTIONED IN CONCLUSION, THIS CASE HIGHLIGHTS THE FEASIBILITY OF MANAGING COMPLEX LIP INJURIES IN A PRIMARY CARE SETTING AND EMPHASIZES THE IMPORTANCE OF PRECISE ANATOMICAL REPAIR, PROPER SUTURE SELECTION, AND NOVEL INTERVENTIONS LIKE MEBO AND SCAR MASSAGE. FURTHER RESEARCH IS NEEDED TO ESTABLISH MEBO'S ROLE IN STANDARD POSTOPERATIVE CARE FOR TRAUMATIC LIP INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248345 | PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male | Required Intervention |