MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-12-10 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[185480587]
(b)(4). 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185480588]
It was reported via journal article: "title: skin closure with 2-octyl-cyanoacrylate and polyester mesh after primary total knee arthroplasty offers superior cosmetic outcomes and patient satisfaction compared to staples: a prospective trial" authors: not reported. Citation: not reported. The aim of this prospective study was to compare the outcomes of patients receiving 2-octyl-cyanoacrylate glue and polyester mesh for skin closure after total knee arthroplasty (tka) versus staples for the following outcomes at 6- and 12 weeks postoperative: (1) visual analog scale (vas) patient satisfaction with wound cosmesis per tka and (2) wound-related complications per tka, including stitch abscess, wound hematoma, wound dehiscence, superficial surgical site infection (ssi), deep ssi, and periprosthetic joint infection (pji), readmission, and reoperation. Between january 15, 2018 to february 27, 2019, 54 patients undergoing 60 tkas were included in the study that were divided into two group: 30 tkas (male=8, female=22; mean age=62? 8 years; mean bmi=33? 5. 2 kg/m^2) were under glue and polyester-mesh group, and 30 patients (male=15, female=15; mean age=62? 7 years; mean bmi=35? 7. 5 kg/m^2) were under control group. For the glue and polyester mesh group, closure of the subcutaneous layer was performed using a unidirectional barbed number 4-0 monofilament absorbable suture (stratafix, number 4 monofilament suture, ethicon) with inverted interrupted knots. The skin edges were approximated using adhesive polyester mesh (prineo, ethicon). 2-octyl cyanoacrylate (glue) (dermabond, ethicon) was applied in a single layer on the polyester mesh and allowed to dry for a minimum of thirty seconds. The wound was then covered with surgical dressing. The polyester mesh was removed during the 4-week post-operative visit. In the glue and polyester mesh group, a (b)(6) year old male patient had superficial ssi. On his post-operative day-4, he required readmission for treatment of severe cellulitis. He left against medical advice before he received intravenous antibiotics and required a second readmission for insert of a peripherally inserted central catheter (picc) line. Ultimately, the patient successfully completed an intravenous course of antibiotics. Also, in the same group, a (b)(6) year old male patient had wound dehiscence. On his post-operative day 11, he fell directly on the operative leg resulting in complete wound dehiscence with exposure of his prosthesis. He was seen in the emergency department and admitted to the hospital where he underwent treatment with debridement, antibiotics, irrigation, and implant retention (dair). He ultimately completed a 4-week course of iv antibiotics followed by an additional 4-week course of oral antibiotics. His wound was completely healed, and he had a well-functioning tka at his last orthopaedic visit. In conclusion, the skin closure with polyester mesh and glue offers superior patient satisfaction and cosmetic outcomes compared to staples for wound closure in tka patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90686 |
| MDR Report Key | 9443531 |
| Report Source | LITERATURE |
| Date Received | 2019-12-10 |
| Date of Report | 2019-11-18 |
| Date Mfgr Received | 2019-11-18 |
| Date Added to Maude | 2019-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-12-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-10 |