MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Swelling (2091)

Event Type  Injury  

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the date of the procedure in 2011? what suture was used during procedure in 2011? what was the date of the second procedure? what suture was used during second procedure? if in your possession, may we have a copy of your operative report (2011, 2nd proc, and aug 2019) for each procedure to review which layer of tissue the suture was used? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact the surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the surgeon¿s name, contact information and sign release of medical information form.Patient reported adverse event of hives, reaction possibly treated with steroid in 2011 reported via 2210968-2019-90131.Patient reported adverse event of hives, reaction and angioedema treated with steroid on unknown date reported via 2210968-2019-90134, 2210968-2019-90135 and 2210968-2019-90137.Patient reported adverse event of hives, reaction, angioedema treated with steroid in august 2019 and current hives reported via 2210968-2019-90138, 2210968-2019-90140 and 2210968-2019-90141.

Event Description

It was reported by the patient that they underwent a knee procedure on unknown date and suture was used.The patient experienced severe allergic reactions 3 to 4 weeks after surgery, not at the site of surgery but systemically with hives and angioedema.The reaction begins with hives and then proceeds to swelling in the face and lips or on the tongue.The patient was treated with doses of prednisone to prevent further reaction.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).This event does not meet reporting criteria therefore, this medwatch report is being voided.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9349089
• MDR Text Key: 181344943
• Report Number: 2210968-2019-90135
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention