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).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

(b)(4).Representative samples were returned for evaluation.They were visually and functionally examined for tensile strength and they met the requirements.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch 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): ETHICON INC. - JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3634536
• MDR Text Key: 3990693
• Report Number: 2210968-2014-01648
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1915G
• Device Lot Number: GB6909
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 02/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2014; 06/18/2014
• 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