MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Seroma (2069); 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.Attempts are being made to obtain 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.(b)(4).

Event Description

Title: the combined application of human acellular dermal matrix and vacuum wound drainage on incarcerated abdominal wall hernias.It was reported in a journal article: the aim of this retrospective review is to describe the authors¿ experience with the use of human acellular dermal matrix (adm) in the repair of incarcerated abdominal wall hernias.From june 2008 to october 2011, 51 males and 12 females, ages 45 to 68 years who underwent for an acute incarcerated abdominal wall hernia and repair with human adm were included in this study.Incarcerated abdominal wall hernia repairs were performed by three experienced surgeons.All procedures were performed under general anesthesia.While exploring the hernia sac and assessing its contents, the operative field was protected from contamination.The intestine was reduced, or necrotic intestine was resected.Anastomoses were performed using double layer 3/0 vicryl interrupted suture.The human adm mesh was placed under near maximal tension, in an intra-abdominal underlay position, and fixed in place using 0-prolene transfacial sutures to the abdominal wall.Recurrence (n=10), bulge (n=8), seroma (n=3) that resolved by percutaneous drainage and superficial wound infection (n=1) that was treated with local wound care and allowed to heal by secondary intention.In conclusion, this study suggests that the use of adm as a biological mesh combined with a high-vacuum wound drainage system in complex abdominal wall reconstruction is acceptable without major side effects.Additional information will be requested.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 7375336
• MDR Text Key: 103657839
• Report Number: 2210968-2018-71692
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/06/2018

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: 03/06/2018
• Initial Date FDA Received: 03/27/2018
• 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