MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-10-16 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[162969788]
(b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. Were the cases 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? 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. Citation: orthopedics. 2018; 41(2):e262-e267; doi: 10. 3928/01477447-20180213-05. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[162969789]
It was reported via a journal article: title: the effects of platelet-rich plasma and activated collagen on wound healing in primary total joint arthroplasty. Author/s: aldo bove,david c. Evans, ba; bruce g. Evans, md. Citation: orthopedics. 2018; 41(2):e262-e267; doi: 10. 3928/01477447-20180213-05. The objective of this (b)(6) study was to determine whether additives would improve wound outcomes and prevent postoperative complications in primary total knee and total hip surgeries. A total of 90 patients with osteoarthritis underwent elective primary total knee or total hip arthroplasty and were randomized into three groups: group 1 (n=30; n=10 male and n=20 female; average body mass index [bmi] of 28. 2? 6. 7 kg/m^2)? Receiving platelet-rich plasma (prp) prior to wound closure; group 2 (n=30; n=13 male and n=17 female; average bmi of 32? 8. 1 kg/m^2)? Receiving activated collagen prior to wound closure; and group 3 (n=30; n=13 male and n=17 female; average bmi of 28. 3? 5. 7 kg/m^2)? Acted as control (without additive). In all patients, dermabond prineo skin closure system (ethicon) was used in skin closure. Postoperatively, overall outcomes included erythema (n=21 at 2 weeks; n=4 at 6 weeks), induration (n=10 at 2 weeks; n=2 at 6 weeks), swelling (n=39 at 2 weeks; n=8 at 6 weeks), wound separation (n=2 at 2 weeks; n=5 at 6 weeks) which required irrigation and closure in one patient, tissue necrosis (n=8 at 2 weeks; n=3 at 6 weeks); elevated scar (n=5 at 6 weeks); and superficial wound infection (n=12 at 6 weeks) cleared with antibiotics in all and one patient required irrigation and debridement with closure over drains. On the basis of this study, these additives are not recommended for routine primary joint arthroplasty; however, the data suggest possible benefits for high-risk patients and those for whom blood loss may be an issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88729 |
| MDR Report Key | 9198292 |
| Report Source | LITERATURE |
| Date Received | 2019-10-16 |
| Date of Report | 2019-09-20 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2019-10-16 |
| 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 | 2019-10-16 |
| Catalog Number | UNK |
| 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 | 2019-10-16 |