MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Erosion (1750); 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.(b)(4).

Event Description

Title: short term outcomes following laparoscopic sacrocolpopexy with partially resorbable ultra-lightweight versus lightweight polypropylene mesh.The authors reported short term outcomes of laparoscopic sacrocolpopexy (lscp) in 159 consecutive patients, using either light weight polypropylene (pp) gynemesh or an ultra-lightweight hybrid ultrapro mesh.This is a prospective study in patients undergoing lsc for symptomatic stage>=2 prolapse at point c.In the ultrapro group, reported complications included adhesions which required conversion in 1 case and mesh exposure (n-2) which required re-intervention.It was reported that there were no relevant differences in the short-term outcomes in patients undergoing lscp with ultra- or lightweight meshes, except for shorter hospital stay.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7495403
• MDR Text Key: 107632573
• Report Number: 2210968-2018-72655
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• 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: 04/10/2018
• 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