MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-02 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[186284872]
(b)(4). Attempts to obtain the following information have been made and no response to date. If further details or the device are received at a later date a supplemental medwatch will be sent. Was the case discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186284873]
It was reported via a journal article a patient underwent a left shoulder hemiarthroplasty on an unknown date and topical skin adhesive was used. Title: severe wound complication due to prineo surgical dressing in shoulder hemiarthroplasty. Authors: ryan c. Pate, md, michael w. Neumeister, md citation: jbjs case connector (2020); 10 (1): e0306. Doi: 10. 2106/jbjs. Cc. 18. 00306 a (b)(6) year old female patient with left shoulder osteoarthritis underwent a left shoulder hemiarthroplasty. During the procedure, the wound was closed using the dermabond prineo system (ethicon). The patient had a severe and progressive reaction during the first 2 weeks that necessitated debridement and skin grafting. Three months after surgery, the patient was doing well. The surgeons using this closure method should be aware of potential reactions that may initially mimic infection. It is important to initiate appropriate treatment including removing the dressing, topical steroids, and/or oral antihistamines, antibiotics, and possible surgical wound debridement. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2210968-2020-01642 |
MDR Report Key | 9774610 |
Report Source | HEALTH PROFESSIONAL,LITERATUR |
Date Received | 2020-03-02 |
Date of Report | 2020-02-05 |
Date Mfgr Received | 2020-03-02 |
Date Added to Maude | 2020-03-02 |
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 | 2020-03-02 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
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 | 2020-03-02 |