PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2025-06550
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- January 15, 2025
- Report Date
- July 1, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- N18331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURG OPEN SCI. 2025 JAN 15;23:69-74. DOI: 10.1016/J.SOPEN.2025.01.002. PMID: 39906220; PMCID: PMC11791243.
MECHANICALLY POWERED NEGATIVE PRESSURE DRESSING REDUCES SURGICAL SITE INFECTION AFTER STOMA REVERSAL. THE AIM OF THIS STUDY IS TO ASSESS 30-DAY WOUND COMPLICATION AND STOMA SITE SSI RATES OF PATIENTS UNDERGOING PRIMARY CLOSURE OF STOMA REVERSAL WOUNDS FOLLOWED BY PLACEMENT OF THIS MP-NPD. WE HYPOTHESIZED THAT THIS NOVEL USAGE OF MP-NPD IN STOMA REVERSAL WOUNDS WOULD IMPROVE SSI AND WOUND COMPLICATION RATES WHEN COMPARED TO TRADITIONAL STOMA CLOSURE TECHNIQUES. BETWEEN MAY 2021 AND MARCH 2022, FORTY-SIX CONSECUTIVE PATIENTS UNDERGOING LOCAL ILEOSTOMY OR COLOSTOMY CLOSURES WERE ENROLLED AND INCLUDED IN THE ANALYSIS. THE AVERAGE AGE WAS 55.6 13.9 YEARS, AND 23 (50 %) PATIENTS WERE FEMALE. THE AVERAGE BODY MASS INDEX (BMI) WAS 27.3 ± 7.7 AND THE MEDIAN ASA GRADE WAS 3 (RANGE 1¿3). NEARLY ALL PATIENTS WERE ASA GRADE 2 OR 3 (45.7 % AND 52.2 %, RESPECTIVELY). FOUR (8.7 %) PATIENTS REPORTED CURRENT TOBACCO USE IN THE PERIOPERATIVE SETTING, 9 (19.6 %) REPORTED A HISTORY OF TOBACCO USE, AND 3 (6.5 %) HAD DIABETES. 23 PATIENTS (50.0 %) RECEIVED SYSTEMIC CHEMOTHERAPY FOR RECTAL OR COLON CANCER. FORTY (87.0 %) PATIENTS UNDERWENT ILEOSTOMY REVERSAL AND 6 (13.0 %) UNDERWENT COLOSTOMY REVERSAL. TWO PATIENTS (4.3 %) REQUIRED CONVERSION TO OPEN LAPAROTOMY DUE TO EXTENSIVE ADHESIONS AND INABILITY TO FULLY MOBILIZE THE BOWEL THROUGH A LOCAL INCISION. THE MAJORITY OF PATIENTS (56.5 %) REQUIRED TEMPORARY DIVERTING STOMA AS PART OF A COLORECTAL CANCER PROCEDURE, FOLLOWED BY DIVERSION FOR MANAGEMENT OF LEAK, INFECTION, OR FISTULA (26.1 %), AND INFLAMMATORY BOWEL DISEASE (13.0 %). ONE (2.2 %) PATIENT REQUIRED DIVERSION DUE TO AN IATROGENIC INJURY AND 1 (2.2 %) REQUIRED DIVERSION DUE TO SEVERE HIDRADENITIS. THE FASCIA WAS CLOSED WITH 0 POLYDIOXANONE (PDS¿ [ETHICON INC., SOMERVILLE, NJ, USA]) SUTURE IN A RUNNING OR INTERRUPTED FASHION. THE SUBCUTANEOUS TISSUE WAS CLOSED USING INTERRUPTED POLYGLACTIN 910 (VICRYL¿ [ETHICON INC., SOMERVILLE, NJ, USA]) SUTURE AND THE SUPERFICIAL SKIN WAS CLOSED WITH RUNNING CUTICULAR 4¿0 POLIGLECAPRONE 25 (MONOCRYL¿ [ETHICON INC., SOMERVILLE, NJ, USA]) SUTURE. ALL WOUNDS WERE IRRIGATED WITH WARM SALINE, IODINE SOLUTION, STERILE WATER, OR A COMBINATION PRIOR TO SKIN CLOSURE. REPORTED COMPLICATIONS ARE THE FOLLOWING: 0 PDS¿ SUTURE (POLYDIOXANONE; ETHICON). -UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD REQUIRED INTRAOPERATIVE BLOOD TRANSFUSION WITH UNKNOWN CAUSE. - UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD 30-DAY READMISSION WITH UNKNOWN CAUSE. - DEVELOPED STOMA SITE SSI WITHIN 30 DAYS OF THE OPERATION (N=1). TREATMENT: NOT REPORTED. - THERE WERE 6 OTHER MINOR WOUND COMPLICATIONS (N=5). TREATMENT: NOT REPORTED. - DEVELOPED SEROMA (N=2). TREATMENT: NOT REPORTED. - EXPERIENCED SUPERFICIAL WOUND DEHISCENCE (N=2). TREATMENT: ONE PATIENT IN THE STUDY GROUP HAD A SMALL 1 CM SUPERFICIAL DEHISCENCE DUE TO SEROMA FORMATION, WHICH SPONTANEOUSLY DRAINED WITHOUT SIGNS OF UNDERLYING INFECTION AND WAS SUCCESSFULLY MANAGED WITH CONSERVATIVE MEASURES. A SECOND PATIENT DEVELOPED SUPERFICIAL SKIN DEHISCENCE OF THE ENTIRE WOUND AND ASSOCIATED SUPERFICIAL SSI WHICH REQUIRED REMOVAL OF MP-NPD DRESSING PRIOR TO DISCHARGE AND MANAGEMENT WITH WET TO DRY GAUZE PACKING. THIS PATIENT HAD COMPLETE WOUND HEALING BY THE TIME OF FIRST FOLLOW-UP VISIT MANAGED CONSERVATIVELY AND DID NOT REQUIRE ADDED ANTIBIOTIC TREATMENT. - DEVELOPED MINOR WOUND BLISTERING AT THE ADHESIVE EDGES OF THE MP-NPD DRESSINGS (N=2) TREATMENT: THESE BLISTERS WERE MANAGED CONSERVATIVELY WITH LOCAL WOUND CARE AND DRY DRESSINGS AS NEEDED WITH RESOLUTION BY TIME OF FIRST FOLLOW-UP VISIT. VICRYL¿ POLYGLACTIN 910 SUTURE( [ETHICON). 0 PDS¿ SUTURE (POLYDIOXANONE; ETHICON). -UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD REQUIRED INTRAOPERATIVE BLOOD TRANSFUSION WITH UNKNOWN CAUSE. - UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD 30-DAY READMISSION WITH UNKNOWN CAUSE. - DEVELOPED STOMA SITE SSI WITHIN 30 DAYS OF THE OPERATION (N=1). TREATMENT: NOT REPORTED. - THERE WERE 6 OTHER MINOR WOUND COMPLICATIONS (N=5). TREATMENT: NOT REPORTED. - DEVELOPED SEROMA (N=2). TREATMENT: NOT REPORTED. - EXPERIENCED SUPERFICIAL WOUND DEHISCENCE (N=2). TREATMENT: ONE PATIENT IN THE STUDY GROUP HAD A SMALL 1 CM SUPERFICIAL DEHISCENCE DUE TO SEROMA FORMATION, WHICH SPONTANEOUSLY DRAINED WITHOUT SIGNS OF UNDERLYING INFECTION AND WAS SUCCESSFULLY MANAGED WITH CONSERVATIVE MEASURES. A SECOND PATIENT DEVELOPED SUPERFICIAL SKIN DEHISCENCE OF THE ENTIRE WOUND AND ASSOCIATED SUPERFICIAL SSI WHICH REQUIRED REMOVAL OF MP-NPD DRESSING PRIOR TO DISCHARGE AND MANAGEMENT WITH WET TO DRY GAUZE PACKING. THIS PATIENT HAD COMPLETE WOUND HEALING BY THE TIME OF FIRST FOLLOW-UP VISIT MANAGED CONSERVATIVELY AND DID NOT REQUIRE ADDED ANTIBIOTIC TREATMENT. - DEVELOPED MINOR WOUND BLISTERING AT THE ADHESIVE EDGES OF THE MP-NPD DRESSINGS (N=2) TREATMENT: THESE BLISTERS WERE MANAGED CONSERVATIVELY WITH LOCAL WOUND CARE AND DRY DRESSINGS AS NEEDED WITH RESOLUTION BY TIME OF FIRST FOLLOW-UP VISIT. 4¿0 MONOCRYL¿ POLIGLECAPRONE 25 SUTURE(ETHICON). 0 PDS¿ SUTURE (POLYDIOXANONE; ETHICON). -UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD REQUIRED INTRAOPERATIVE BLOOD TRANSFUSION WITH UNKNOWN CAUSE. - UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD 30-DAY READMISSION WITH UNKNOWN CAUSE. - DEVELOPED STOMA SITE SSI WITHIN 30 DAYS OF THE OPERATION (N=1). TREATMENT: NOT REPORTED. - THERE WERE 6 OTHER MINOR WOUND COMPLICATIONS (N=5). TREATMENT: NOT REPORTED. - DEVELOPED SEROMA (N=2). TREATMENT: NOT REPORTED. - EXPERIENCED SUPERFICIAL WOUND DEHISCENCE (N=2). TREATMENT: ONE PATIENT IN THE STUDY GROUP HAD A SMALL 1 CM SUPERFICIAL DEHISCENCE DUE TO SEROMA FORMATION, WHICH SPONTANEOUSLY DRAINED WITHOUT SIGNS OF UNDERLYING INFECTION AND WAS SUCCESSFULLY MANAGED WITH CONSERVATIVE MEASURES. A SECOND PATIENT DEVELOPED SUPERFICIAL SKIN DEHISCENCE OF THE ENTIRE WOUND AND ASSOCIATED SUPERFICIAL SSI WHICH REQUIRED REMOVAL OF MP-NPD DRESSING PRIOR TO DISCHARGE AND MANAGEMENT WITH WET TO DRY GAUZE PACKING. THIS PATIENT HAD COMPLETE WOUND HEALING BY THE TIME OF FIRST FOLLOW-UP VISIT MANAGED CONSERVATIVELY AND DID NOT REQUIRE ADDED ANTIBIOTIC TREATMENT. - DEVELOPED MINOR WOUND BLISTERING AT THE ADHESIVE EDGES OF THE MP-NPD DRESSINGS (N=2) TREATMENT: THESE BLISTERS WERE MANAGED CONSERVATIVELY WITH LOCAL WOUND CARE AND DRY DRESSINGS AS NEEDED WITH RESOLUTION BY TIME OF FIRST FOLLOW-UP VISIT. IN CONCLUSION, USE OF A MP-NPD DRESSING ON PRIMARILY CLOSED ILEOSTOMY AND COLOSTOMY REVERSAL WOUNDS WAS FEASIBLE AND SAFE WITH A VERY LOW STOMA SITE SSI RATE. THE APPLICATION OF THIS SIMPLE NEGATIVE PRESSURE DRESSING SHOULD BE CONSIDERED FOR PATIENTS UNDERGOING PRIMARY WOUND CLOSURE AFTER INTESTINAL STOMA REVERSAL. FURTHER LARGE PROSPECTIVE RCTS ARE NEEDED TO BETTER EVALUATE THIS TECHNIQUE COMPARED TO MORE UNIVERSALLY ACCEPTED STOMA CLOSURE METHODS TO BETTER CORROBORATE THESE FINDINGS. CURRENT PROSPECTIVE RCTS ARE UNDERWAY AT OUR INSTITUTION TO FURTHER EVALUATE TIME TO WOUND CLOSURE AND COMPLETE WOUND HEALING WHEN COMPARING CONVENTIONAL PURSE-STRING STOMA CLOSURES TO PRIMARY STOMA CLOSURE AND PLACEMENT OF MP-NPD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1476527 | PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |