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

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Pneumonia (2011); Infection, Pyrogenic (2246); Post Operative Wound Infection (2446); Not Applicable (3189)

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 the ethicon products involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe there was any deficiency with the ethicon suture products used in this procedure? citation: indian j surg.2016; 78(5): 371 374.Doi: 10.1007/s12262-016-1484-z.(b)(4).

Event Description

It was reported via journal article: "title: thoracotomy for traumatic diaphragmatic hernia" author: zhang fangbiao, zheng chunhui, zhao chun, shi hongcan, zhang xiangyan, tu shaosong web address: doi 10.1007/s12262-016-1484-z citation: indian j surg.2016; 78(5): 371 374.Doi: 10.1007/s12262-016-1484-z.The aim of this retrospective study was to review the authors experience in the diagnosis and role of thoracotomy for traumatic diaphragmatic hernia (tdh).Between january 2008 and june 2014, a total of 23 patients (18 males and 5 females; age range: 15 to 68 years old) from yangzhou medical college (yangzhou china) and lishui center hospital (lishui china), who underwent thoracotomy for tdh, were analyzed.During the procedure, once the diagnosis of tdh is suspected or confirmed, the patients were immediately prepared for thoracotomy depending on the site of injury and imaging features.The herniated tissues and the defect in the diaphragm were assessed.After the abdominal contents were reduced through the defect, the diaphragmatic defect was repaired using interrupted prolene sutures.The post-operative complications included wound infection (n-1, 4.3 %), pneumonia (n-4, 17.4 %), empyema (n-2, 8.7 %), and anemia (n-5, 21.7 %).The following complications were treated successfully.One patient died due to serious pneumonia.It was reported that the preoperative diagnosis of tdh is still a challenge.Once the diagnosis of tdh is suspected or confirmed, thoracotomy or laparotomy is required immediately.In the reported cases, herniated abdominal organs were placed back into the abdomen and the defect was successfully repaired with interrupted sutures via a thoracotomy.It was concluded that thoracotomy of tdh is successful and effective, but sometimes, it needs an additional complex procedure like enterectomy or splenectomy.

• 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: 7654361
• MDR Text Key: 112858843
• Report Number: 2210968-2018-73971
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

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
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/02/2018
• 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