MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 04/23/2020

Event Type  Injury  

Event Description

Title: polyester mesh dressings reduce delayed wound healing rates after total hip arthroplasty compared with silver-impregnated occlusive dressings this retrospective study aims to compare the standard dressing ,an aquacel ag dressing with or without n-butyl-2-cyanoacrylate adhesive with the novelmesh , a combination of the skin glue 2-octyl cyanoacrylate adhesive and a polyester mesh (dermabond prineo, ethicon, somerville, nj), dressing for total hip arthroplasty (tha). Between january 2017 and may 2019, four hundred and thirty one consecutive total hip arthroplasty (thas) performed by 2 surgeons were identified. One hundred and eight were excluded for not using either dressing type. Thus, 323 cases were separated into 2 concurrent cohorts: mesh (n
=
186) with 51. 61% male patients age 64. 64 years and standard dressings (n
=
137) with 61. 31% male patients age 66. 74 years. After wound closure, in the standard dressing group, an aquacel ag bandage was applied with all edges sealed. In the mesh group, the polyester mesh , dermabond prineo (ethicon) was sized and placed on the incision lengthwise followed by 2-octyl cyanoacrylate adhesive and full polymerization. Aquacel ag dressings were removed at 1 week and mesh persisted until nonadherent, generally past 3-4 weeks. The attending surgeon assessed the patient for delayed wound healing at the initial 2-week office visit or sooner if contacted by the patient, visiting nurse, or posteacute care facility. Reported complication included: (n
=
7) cases of delayed wound healing. (n
=
2) deep infections. (n
=
?) wound complications. It was concluded, that in this cohort of patients, mesh dressings appear to be a safe and reliable dressing option for total hip arthroplasty (tha) and are associated with a decrease in early wound healing complications when compared to standard, silver-impregnated occlusive dressings at 2weeks. Further research is needed to determine whether or not this early decrease in wound complications confers reduced risk for surgical site infection (ssi) or prosthetic joint infection (pji).

Manufacturer Narrative

Product complaint # (b)(4). Device not returned. 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. Does the surgeon believe that any of the ethicon products involved (prineo) caused and/or contributed to the post-operative complications (delayed wound healing, deep infections, wound complication) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products ( prineo) used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events citation: arthroplasty today 6 (2020) 158-162. Https://doi. Org/10. 1016/j. Artd. 2020. 01. 0132352-3441/. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13053732
• MDR Text Key: 288287448
• Report Number: 2210968-2021-12823
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2021 Patient Sequence Number: 1