MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported by the sales rep that a patient underwent an unknown procedure and suture was used.The patient developed an infection.Additional information has been requested.

Manufacturer Narrative

(b)(4): no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.Additional information: the actual product associated with this event is not known.The account reports 3 possible products vicryl plus; monocryl plus; pds plus.

• Brand Name: SUTURE UNKNOWN
• Type of Device: NI
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3630782
• MDR Text Key: 3985462
• Report Number: 2210968-2014-01567
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other