MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Discomfort (2330); Deformity/ Disfigurement (2360); No Code Available (3191)

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.If further details are received at the later date a supplemental medwatch will be sent.Citation: j oral maxillofac surg.2010; 68: 686 690.Doi: 10.1016/j.Joms.2009.04.128.(b)(4).

Event Description

It was reported in journal article title: nasal base modification in asian patients authors: sang-ha oh, md, da-arm kim, md, jae yong jeong, md.Citation: j oral maxillofac surg.2010; 68: 686 690.Doi: 10.1016/j.Joms.2009.04.128.The authors described their experience with narrowing the alar base in cases with a wide nasal base and alar flaring using a procedure that combines alar rim resection and an alar cinching suture.A total of 45 patients (43 women and 2 men) with excessive alar flaring or a wide nasal base underwent nasal modification and were included in the study.Nasal base modification was performed as the final step in a rhinoplasty because any change in the nose will have a direct effect on the nasal base configuration.The resection is closed in 2 layers with pds 5-0 subcutaneous sutures to help evert the skin edges, which are then closed with nylon sutures for the part outside the nostril rim and vicryl 5-0 sutures inside the nostril.Reported complications included recurring deformities (n-6) and worsening of nostril asymmetry (n-3); both required revision surgery, and temporary swelling and discomfort in the premaxillary area (n-6) resulting from an excessive cinching suture and the complications resolved spontaneously.It was reported that the use of cinching suture for wide noses with excessive flaring must be limited because it can lead to bunching of the floor of the nostrils and excessive rounding of the alae.Another important limitation of the cinching suture technique is that it results in symmetric medialization of the alae only, which makes it inapplicable in cases with asymmetric nostrils.It was also reported that excessive cinching tension can cause premaxillary swelling and discomfort while smiling.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7407744
• MDR Text Key: 104732622
• Report Number: 2210968-2018-72022
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N18331
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• 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
• Date Manufacturer Received: 03/21/2018
• 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