MAUDE Adverse Event Report: ETHICON INC. SURGICAL GUT SUTURE -PLAIN; SUTURE, ABSORBABLE, NATURAL

Catalog Number H810H

Device Problem Reaction (1514)

Patient Problem Reaction (2414)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent an unknown dental surgical procedure on an unknown date and suture was used.Following the procedure, the patient experienced a post-surgical reaction.Additional information has been 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.

• Brand Name: SURGICAL GUT SUTURE -PLAIN
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4371083
• MDR Text Key: 20119808
• Report Number: 2210968-2014-17131
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K946173
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H810H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• 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