MAUDE Adverse Event Report: ETHICON INC. MONOCRYL (POLIGLECAPRONE 25) SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number W3213

Device Problems Reaction (1514); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Scarring (2061); Skin Discoloration (2074); Reaction (2414); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that the patient underwent plastic surgery procedure on an unknown date and suture was used.Approximately 6-8 months following the procedure, the patient experienced red indented markings where the suture has been placed.The patient was administered steroids.It was reported the reaction is severe with scarring in a large red wavy line that lasts for approximately 12 or more months and the patient is unhappy with the appearance of their skin following the procedure.The surgeon opined it is either an allergy or might be the chemicals that are released as the suture is absorbed causing a reaction.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: MONOCRYL (POLIGLECAPRONE 25) SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-UK; simpson parkway, kirkton campu; s; livingston EH54 7AT; UK EH54 7AT
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4757438
• MDR Text Key: 5889218
• Report Number: 2210968-2015-05385
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W3213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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