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

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: bmj case rep.2017.Doi: 10.1136/bcr-2016-218571.(b)(4).

Event Description

It was reported via journal article: "title: tension enterothorax and hepatothorax due to a diaphragmatic hernia: successful emergency repair of a life-threatening condition" authors: eirini martinou, piers gatenby citation: bmj case rep.2017.Doi: 10.1136/bcr-2016-218571.Diaphragmatic hernias are broadly classified to congenital and acquired categories.This report aims to highlight the fact that successful repair of complicated diaphragmatic hernias are feasible and safe in experienced hands.A (b)(6) female patient was presented to the hospital with acute severe respiratory syndrome.Imaging studies showed tension enterothorax and hepatothorax with tracheal deviation.The patient underwent an emergency laparotomy with preparations made for the possibility of a right thoracotomy.The patient was found to have a tight diaphragmatic hernia through the central tendon.The diaphragmatic defect was repaired with interrupted ethibond excel 2 sutures and was re-enforced with a physiomesh 15×15 cm using prolene 3-0 sutures.The right basal and apical chest drains were placed.During the last follow-up appointment, the patient reported shortness of breath and the computed tomography (ct) scan showed recurrence of hernia.It was concluded that the unusual case of acute respiratory failure secondary to a diaphragmatic hernia where timely diagnosis and management at a unit where thoracic and abdominal surgery could be undertaken were vital for the successful outcome.

• 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: 7595843
• MDR Text Key: 110909186
• Report Number: 2210968-2018-73441
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

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: 05/23/2018
• Initial Date FDA Received: 06/13/2018
• 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
• Patient Age: 70 YR