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

Device Problem Insufficient Information (3190)

Patient Problems 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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the 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: hernia (2017) 21:795¿798; doi 10.1007/s10029-017-1589-8.[(b)(4) - abo-ryia 2017 (1).Pdf].

Event Description

It was reported via journal article title: simple and safe technique for closure of midline abdominal wound dehiscence author: m.H.Abo-ryia citation: hernia (2017) 21:795¿798; doi 10.1007/s10029-017-1589-8; published online: 13 february 2017.The aim of this study was to assess an alternative technique for closure of burst abdomen.Between december 2012 to june 2015, 11 patients (6 males and 5 females) with burst midline exploratory abdominal wound were included in the study.During the procedure, the omentum is fixed to the peritoneal side of the wound edge all-around with interrupted prolene 3/0 sutures.A piece of polypropylene mesh was designed according to the size and shape of the defect to close it without tension and sutured to the edges of the wound with continuous 0 prolene suture.Another larger polypropylene mesh was placed to cover the smaller one and extend over the aponeurosis exceeding the defect edges by at least 5¿6 cm and fixed all-around in circles of interrupted 2/0 prolene sutures till the wound edges.After irrigation of the wound area with normal saline solution suction drains were placed and the skin was closed with interrupted 2/0 prolene stitches.Wound infection occurred in five patients in the form of local redness and tenderness responded to conservative treatment in three of them while one case needed local drainage and one was due to stitch sinus cured by extraction of the offending stitch.In conclusion, this technique provides a simple, safe and effective alternative in the treatment of burst abdomen.

• 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: 7627349
• MDR Text Key: 111984027
• Report Number: 2210968-2018-73650
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 05/29/2018

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: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• 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