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

Catalog Number 1915G

Device Problem Absorption (1003)

Patient Problem Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a blepharoplasty on an unknown date and suture was used.Six months post-op, the suture had not absorbed and had to be removed by the surgeon.No further information was provided.

Manufacturer Narrative

(b)(4).The actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.The device met performance specifications.The actual device batch number associated with this event is not known.The account reports the following possible batch numbers: batch 48854isp, mfg date: 01/29/2009, exp date: 12/31/2013.Lot # eck281 - mfg date: 03/01/2012; exp date: 01/31/2017.Lot # ga5590 - mfg date: 01/01/2013; exp date: 01/31/2018.Lot # ghk099 ¿ mfg date: 07/01/2013; exp date: 07/31/2018.

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.

Manufacturer Narrative

In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.

• 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: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3634604
• MDR Text Key: 3989666
• Report Number: 2210968-2014-01653
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1915G
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2014
• 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