MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the patient that the underwent a foot surgery on (b)(6)2019 and suture was used.Following the procedure, the patient¿s skin got supersensitive and a little bit red.The patient had first post-op appointment on (b)(6)2019.The physician removed the dressings and some stitches and covered the patient¿s foot with a large band aid and patient was instructed to start physical therapy in about a week.On (b)(6)2019, the patient had their first physical therapy appointment.The therapist looked at the patient¿s foot and patient explained that the skin around the incisions had been extremely sensitive and was painful to even lightly touch.The physical therapist explained that the dissolving stitches hadn't completely dissolved and that she would need to remove them.She began touching the stitches with tweezers, lifting the edges lightly to see where to start.The patient reported that this was so painful they got nauseous.The physical therapist was only able to remove some of the stitches and the rest of the stitches were removed at the next appointment with the almost the same level of pain while extracting them.The patient had final follow-up with physician on (b)(6)2019.The patient reported that the physician opined the patient had the symptoms of being hypersensitive to topical skin adhesive.No additional information was provided.

Manufacturer Narrative

(b)(4).Additional information obtained: the patient had follow-up with physician on 06/03/2019.The patient reported that the original foot procedure was neuroma decompression surgery.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8444374
• MDR Text Key: 139578461
• Report Number: 2210968-2019-79611
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Patient Sequence Number: 1