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

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Post Operative Wound Infection (2446); Not Applicable (3189)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.Citation: j reprod med.2011 may-jun; 56(5-6):187-91; (b)(4).

Event Description

It was reported in journal article title: overlapping anal sphincteroplasty: impact of suture selection on bowel symptoms authors: parnell ba, whitehead we, geller ej, jannelli ml and connolly a.Citation: j reprod med.2011 may-jun; 56(5-6):187-91; the aim of this study was to look at women who underwent overlapping anal sphincteroplasty (oas) with the use of either permanent or absorbable sutures and to describe patient-reported fecal continence and quality of life.The study includes 40 women who underwent oas from july 1997 to january 2008.Of the women enrolled in the study, 20 had surgery using permanent sutures, and the remaining 20 women had absorbable sutures used (vicryl and pds).Post-operative wound complications were uncommon for both groups.Six women in the permanent suture group experienced a wound separation and 3 women had a wound infection, all treated conservatively.The permanent suture group had 3 suture erosions that were each managed in the clinic setting.In the absorbable suture group, 5 wounds had wound separations with 2 wound infections, which was also managed conservatively.One patient, who had her oas done using pds, experienced suture erosion.This was also managed in the clinic setting.With no increase in surgical or postoperative morbidity, the permanent group displayed less overall severity of their fecal incontinence symptoms and experienced fewer social limitations that the absorbable suture group.In conclusion, while overall patient-reported fecal incontinence was similar for the two groups, permanent suture use at time of oas was associated with decreased fecal incontinence severity and fewer social limitations.Future directions of this work could include a multi-centered, randomized, controlled trial to further clarify the role for permanent suture at the time of oas.

• 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: 7429924
• MDR Text Key: 105516156
• Report Number: 2210968-2018-72133
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention