BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7379161 · Received March 28, 2018

    Report

    Report Number
    2210968-2018-71720
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: (J TRAUMA. 2011; 71: 1512¿1518); DOI: 10.1097/TA.0B013E31823D0691 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: SAFETY OF PERFORMING A DELAYED ANASTOMOSIS DURING DAMAGE CONTROL LAPAROTOMY IN PATIENTS WITH DESTRUCTIVE COLON INJURIES¿. AUTHORS: CARLOS A. ORDONEZ, MD, LUIS F. PINO, MD, MARISOL BADIEL, MD, MSC, ALVARO I. SA´NCHEZ, MD, MS, JHON LOAIZA, BSC, LEONARDO BALLESTAS, MD, AND JUAN CARLOS PUYANA, MD CITATION: (J TRAUMA. 2011; 71: 1512¿1518); DOI: 10.1097/TA.0B013E31823D0691. THIS COMPARATIVE RETROSPECTIVE REVIEW AIMED TO EVALUATE THE SAFETY AND FEASIBILITY OF PERFORMING DELAYED ANASTOMOSIS (DA) IN PATIENTS UNDERGOING DAMAGE CONTROL LAPAROTOMY (DCL) FOR DESTRUCTIVE COLON INJURIES (DCIS) VERSUS PATIENTS MANAGED WITH COLOSTOMY WITH OR WITHOUT DCL. BETWEEN 2003 AND 2009, 60 PATIENTS WITH SEVERE GUNSHOT WOUNDS AND THREE PATIENTS WITH STAB WOUNDS WERE PRIMARILY INCLUDED IN THE STUDY. DCL WAS REQUIRED IN 30 PATIENTS, ALL WITH GUNSHOT WOUNDS. THREE PATIENTS DIED WITHIN THE FIRST 48 HOURS, 3 UNDERWENT COLOSTOMY, AND 24 WERE MANAGED WITH DA. THIRTY-THREE PATIENTS WERE MANAGED WITH STANDARD LAPAROTOMY: 26 PATIENTS WITH PRIMARY ANASTOMOSIS AND 7 WITH COLOSTOMY. IN SUMMARY, THERE WERE 27 MALE PATIENTS, AGES 18 TO 42 YEARS WHO UNDERWENT DCL WITH DA AND 26 (22 MALES AND 4 FEMALES AGES 22 TO 41 YEARS) WHO UNDERWENT STANDARD LAPAROTOMY (SL) WITH PRIMARY REPAIRS (PR). FOR DA¿S, A CONTINUOUS SINGLE-LAYER VICRYL 3-0 SUTURE WAS USED; PREFERABLY DURING THE FIRST OR SECOND RELAPAROTOMY. IN CASES WHERE A DEFINITIVE CLOSURE OF THE FASCIA COULD NOT BE PERFORMED, THE SKIN WAS CLOSED WITH AN INTERRUPTED PROLENE 2-0 SUTURE. ANASTOMOTIC LEAKS (N=2); 1 PATIENT DEVELOPED ANASTOMOTIC LEAK IN THE RIGHT COLON AND 1 DEVELOPED THE ANASTOMOTIC LEAK IN THE LEFT COLON, PANCREATIC COMPLICATIONS (N=2), 1 PANCREATIC ABSCESS AND 1 SEVERE POSTTRAUMATIC PANCREATITIS, INTRA-ABDOMINAL ABSCESSES (N=16) ASSOCIATED WITH A POSITIVE CULTURE AND INFLAMMATORY RESPONSE THAT REQUIRED RE-LAPAROTOMY, FASCIITIS OF THE ABDOMINAL (N=3) THAT REQUIRED DEBRIDEMENT AND ANTIBIOTIC THERAPY. THE 3 PATIENTS IN WHOM A COLOSTOMY WAS PERFORMED DEVELOPED PERSISTENT INTRA-ABDOMINAL ABSCESSES WITH SEVERE COLONIC WALL EDEMA AND INFLAMMATION, AND ACIDOSIS. IN CONCLUSION, DA DURING DCL IN PATIENTS WITH DCI IS A RELIABLE AND FEASIBLE TECHNIQUE WHICH COULD BE CONSIDERED AS AN OPTION IN PATIENTS WITH DCI, EXCEPT IN THOSE PRESENTING WITH RECURRENT INTRA-ABDOMINAL ABSCESSES, SEVERE BOWEL WALL EDEMA AND INFLAMMATION, OR PERSISTENT METABOLIC ACIDOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219347 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention