MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN USP6-0; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z1721H

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.Devices captured in mw 2210968-2019-80514; 2210968-2019-80517; 2210968-2019-80518; 2210968-2019-80520 and 2210968-2019-80521.

Event Description

It was reported that the patient underwent nose reconstruction procedure on (b)(6) 2018 and suture was used.In (b)(6) 2018 the patient experienced significant nasal edema, hyperemia, itching, pain, face numbness, especially on the face left side.The patient experienced discomfort and reported that some suture parts were coming out.In (b)(6) 2019, the sutures that were used during the procedure on (b)(6) 2018 started to come out in crystallized form from the nasal cavity.During the reoperation on (b)(6) 2019, many suture knots were found at the incision site, that were used on (b)(6) 2018.It was found that the suture, wasn't absorbed after 238 days.After the reoperation on (b)(6) 2019, crystallized suture pieces continue to come out from the nasal cavity.No additional information was provided.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lpm862 number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).It was reported by the attorney: communication was made to the patient advising that we agree to the suture being cut in half and returned to us for testing.The patient was advised that high resolution photographs of the explanted suture before it is cut and after it is cut, along with a description of how it was cut, must be sent to us at the same time that the suture is returned.The patient indicated that she is no longer willing to provide the suture.A manufacturing record evaluation was performed for the finished device lpm862 number, and no non-conformances were identified.

• Brand Name: PDSII VIO 27IN USP6-0
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8529771
• MDR Text Key: 142463975
• Report Number: 2210968-2019-80521
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: Z1721H
• Device Lot Number: LPM862
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention