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

Device Problem Implant extrusion (2154)

Patient Problems Extrusion (1844); Inflammation (1932)

Event Date 03/28/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent an unknown surgical procedure on an unknown date and suture was used.The patient experienced inflammation and frequent extrusion of sutures, including the deeper sutures, in the breast region.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

• 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.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 1224 0-90; BR 12240-908
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3884672
• MDR Text Key: 4673358
• Report Number: 2210968-2014-07941
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• 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
• Date Manufacturer Received: 04/25/2014
• 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