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

Catalog Number Y497G

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Erythema (1840); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Swelling (2091)

Event Date 03/25/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a breast reduction procedure on an unknown date and suture was used.One to two weeks post-op, the patient developed swelling and erythema.The erythema had resolved, but the patient continued to have thickening scar formation and residual pain.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion code: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(6).

Manufacturer Narrative

Date sent to the fda: 09/16/2015.Additional narrative: it was reported that the patient underwent a breast reduction procedure on (b)(6) 2015.There were no pre-existing signs of infection prior to the patient's bilateral breast reduction procedure and the immediate post-operative results were good.The patient began having a reaction approximately one month from the surgery date.The first symptom was noted during (b)(6) 2014 appointment, when the patient described a localized redness that was predominately near the fold of the breast.The next complaint came on (b)(6) 2015 visit.The patient had noticeable swelling around the areola, firmness of the breast and some retraction of the incision line.The patient was complaining of shooting pains in the breast and increased edema.It was reported that on (b)(6) 2015, the patient had continued symptoms of an inflammatory reaction.The patient was still complaining of pain and hardness and the retraction of the incision was not improving.At this time, no medical intervention has been taken due to the continued swelling of the patient¿s breast and reaction to a lot of medications.It was reported that there was no activity that increased or decreased the patient¿s symptoms.The patient has had consistent pain and swelling since surgery.(b)(4).

Manufacturer Narrative

Date sent to the fda: 11/03/2015.It was reported that the surgeon noted the significant redness and swelling of the patient¿s breasts at the three week post-op visit.There was concern for infection and so the patient was sent for a blood test which did not show any white blood cell elevation.The patient showed some improvement in her symptoms.However, there was evidence of scar retraction and the patient complained of pain in her breasts.The patient was noted to still be inflamed and expressed concern of potentially having an allergy to the suture material.At the patient¿s last visit, the patient still noted to have some tenderness on examination of her breasts and the scar retraction.There is persistent concern that this is related to an allergy to the suture material.This medwatch report is in response to receipt of maude event report mw5056809.

• 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 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4874661
• MDR Text Key: 16310435
• Report Number: 2210968-2015-07634
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: Y497G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: No
• 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