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

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The events were reported through a journal article and it is unknown if the events have been previously reported.No product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.

Event Description

It was reported in a journal article entitled: retrospective analysis of sutureless skin closure in cleft lip repair author: rajshekhar halli, mds; ajit joshi, mds; yogesh kini, mds, dnb; viraj kharkar, mds; manjula hebbale, mds citation: the journal of craniofacial surgery & volume 23, number 1, january 2012; doi: 10.1097/scs.0b013e318241db01.The aim of this retrospective comparative study was to evaluate the results of skin closure with amcrylate in comparison to suturing with 6-0 prolene in cleft lip repair.The study included 60 patients with unilateral or bilateral cleft lip cases and were randomly divided into 2 groups of 30 patients each, wherein the control group (group 1) with 12 males and 18 females consisted of skin closure with 6-0 prolene and the study group (group 2) with 16 males and 14 females consisted of skin closure with amcrylate (iso amyl 2-cyanoacrylate).A standard surgical protocol for cleft lip repair using millard¿s advancement-rotation technique performed by a single surgeon was used in both groups to avoid bias.The repair was a 3-layer closure: mucosa, muscle, and skin.The skin edges were sutured using 6-0 prolene in group 1.Wound infection occurred in 1 of the patients in group 1.In conclusion, excellent cosmetic results were obtained using amcrylate, which was assessed by 5 different observers as per vas and significance testing with mann-whitney test.Three of 5 observers voted in favor of cyanoacrylate to produce better cosmetic results and the remaining 2 voted against the use of cyanoacrylate with only a minimal statistical difference.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7635097
• MDR Text Key: 112281375
• Report Number: 2210968-2018-73756
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/08/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/25/2018
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention