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 Granuloma (1876); Scarring (2061); Skin Discoloration (2074); Reaction (2414); Treatment with medication(s) (2571)

Event Date 03/01/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent delayed breast reconstruction using a diep with flap to replace the implant on an unknown date and suture was used.Approximately 3-6 months following the procedure, the patient experienced red indented markings where the suture has been placed, described as red wiggly lines.The patient was administered steroids.It was reported, the reaction is severe, forming exact red lines that do not fade or go down even over a long period of time and scars are still seen up to 12 months after surgery.It was reported that the patient is unhappy with the appearance of their scarring following the procedure.The surgeon opined it is either an allergy or might be a reaction to the chemicals that are released as the suture is absorbed.It was reported that a biopsy from breast noted palisaded necrobiotic granulomata resembling granuloma annulare.

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): UNKNOWN; unknown; x
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4973719
• MDR Text Key: 6082057
• Report Number: 2210968-2015-10880
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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: 07/17/2015
• 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