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

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

Patient Problems Inflammation (1932); Discharge (2225); Treatment with medication(s) (2571)

Event Date 07/10/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a parathyroidectomy procedure on (b)(6) 2015 and suture was used.One day post operatively, the incision was inflamed and had discharge.The patient was seen by his surgeon for follow-up on 7/13/15, and is being treated with antibiotics and methylprednisolone.Additional information was 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.

Manufacturer Narrative

Date sent to the fda: 11/10/2015.Additional narrative: during the procedure, the suture was used for a subcuticular wound closure as a continuous stitch in the subcuticular layer.The surgeon opined that the skin tissue was excellent where the suture was placed.The incision was 4 cm in length over the lower neck in a natural skin crease and no dressing was applied over the incision.On (b)(6) 2015, the wound and the entire front of the neck were red and oozing.The area of reaction covered at least sixty-four square centimeters.The patient was started on oral antibiotics, oral steroids, topical antibiotics and topical steroids and seen every forty-eight hours.The surgeon stated that the patient improved significantly and on (b)(6) 2015 the inflammation was reduced by ninety percent.

• 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: 4976312
• MDR Text Key: 6082186
• Report Number: 2210968-2015-10942
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 68