MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Abnormal Vaginal Discharge (2123); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: cell biochem biophys.Doi: 10.1007/s12013-012-9376-8 (b)(4).

Event Description

It was reported via journal article title: a retrospective analysis of the effectiveness of a modified abdominal high uterosacral colpopexy in the treatment of uterine prolapse author: y.Cunjian ¿ l.Li ¿ w.Xiaowen ¿ l.Shengrong ¿ x.Hao ¿ l.Xiangqiong citation: cell biochem biophys.Doi: 10.1007/s12013-012-9376-8.The purpose of the study was to evaluate the clinical value of a novel method for high uterosacral colpopexy in the treatment of uterine prolapse.A total of 31 cases (age range: 42 to 83; bmi: 19.10 to 31.22) with severe pelvic organ prolapse diagnosed by pelvic organ prolapse quantification (pop-q) system received a novel high sacral colpopexy method and were included in the study.During the procedure, the uterosacral ligament was reefed and sutured with mersilk 7-0 suture to shorten the uterosacral ligament.A new uterosacral ligament compound body was made by an 8-type method, which plicate suturing both uterosacral ligaments two or three times.These ligaments were sutured at an interval distance of 1 cm, in a top-down fashion, with pds 0 thread.The suture was then used to secure the new uterosacral ligament compound body to the interspinous ligaments of the s1¿s3.Reported complications included lymphatic leakage on the third day after operation (n-1) which required oral administration of atropine and the patient¿s symptoms disappeared and prolapse of the anterior vaginal wall (n-2).It was concluded that the high uterosacral colpopexy surgical approach has the advantages of short operation time, less trauma to the body, less blood loss, and low postoperative recurrence rate.The surgery not only reduces the postoperative recurrence rate, but also effectively improves the quality of the patient¿s sex life.It is a safe and effective method for the treatment of uterine prolapse.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7687405
• MDR Text Key: 114005347
• Report Number: 2210968-2018-74351
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention