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 Cyst(s) (1800); Granuloma (1876); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.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.Attempts are being made to clarify 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 ethicon products (prolene suture, ethibond suture, pds ii suture, vicryl suture and vicryl rapide suture) involved caused and/or contributed to post-operative complications described in the article (postop bleeding, painful cyst, suture sinus/granuloma, pain associated with sutures, pain in scar)? please specify.Does the surgeon believe there was any deficiency with the ethicon products (prolene suture, ethibond suture, pds ii suture, vicryl suture and vicryl rapide suture) used in this procedure/study? please specify.If yes, please provide patient demographics for patients that experienced the post-operative complications (postop bleeding, painful cyst, suture sinus/granuloma and pain associated with sutures) and details of events if available.Please provide medical/surgical intervention for cases with post-op complications (postop bleeding, painful cyst, suture sinus/granuloma, pain associated with sutures).Were all these cases with above post-op complications discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: boam t et al., outcomes following emergency fixation of torted and non-torted testes, journal of pediatric urology, https://doi.Org/10.1016/j.Jpurol.2021.05.016.Events were submitted via 2210968-2021-08194, 2210968-2021-08195, 2210968-2021-08197, 2210968-2021-08198, 2210968-2021-08199, 2210968-2021-08200 and 2210968-2021-08201.

Event Description

Title: outcomes following emergency fixation of torted and non-torted testes.The present study aims to explore in detail whether the method of testicular fixation, sutured or suture-less, has any impact on the risk of complication, reattendance or reoperation in emergency paediatric scrotal explorations, in a single institution.A review of all emergency scrotal explorations performed in children under the age of 18 between 2008 and 2018 in a tertiary paediatric surgery unit was undertaken.At this institution, children with a diagnosis of acute painful scrotum are referred directly to the paediatric surgery service for assessment of the testes that were fixed with sutures, the most common non-absorbable material used was polypropylene (prolene, ethicon, followed by polyethylene terephthalate (ethibond, ethicon).Absorbable sutures used included polydioxanone (pds ii, ethicon) and polyglactin 910 (vicryl, ethicon) or vicryl rapide, ethicon.Reported complications included postop bleeding, painful cyst, suture sinus/granuloma, pain associated with sutures.In conclusion it is likely that influences on complications and reoperations are multifactorial and cannot be attributed solely to the method of testicular fixation.Adoption of a standardized approach to emergency fixation of testes within or across institutions may be a potential avenue for future studies.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12444087
• MDR Text Key: 270599769
• Report Number: 2210968-2021-08196
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/20/2021

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
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/08/2021
• 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