MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-18 for PRINEO 22 SKIN CLOSURE SYSTEM CLR222 manufactured by Ethicon Inc..
[162979012]
(b)(4). The following additional information was requested and obtained: clr222us15 /prineo was entered as product code. However, event describes dermabond advanced. Please verify what was used dermabond advanced or prineo? Prineo was initially applied then fell off; when bleeding stopped the nurse practitioner applied dermabond advanced on the post op floor provide product code? What degree of flexion was the knee when prineo was applied? 90-120. How many layers of adhesive were used over wound during application? One. Was anything else place on the wound after dermabond applied? N/a. Was a dressing placed over the incision? If so, what type of cover dressing used? Why was dermabond advanced used for wound closure instead of prineo? What is the physicians opinion of the contributing factors for the oozing and the prineo coming off? What is the most current patient status? Patient has not been readmitted no further info provided. Follow up meeting with nurse practitioner she reported the patient was not readmitted after this stay; physician is unsure of the reason for additional oozing; no further information provided to report. 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.
Patient Sequence No: 1, Text Type: N, H10
[162979013]
It was reported a patient underwent a total knee arthroplasty on (b)(6) 2019 and topical skin adhesive was used. Post-operatively the adhesive fell off due to oozing underneath the device. Once they had stopped the oozing, she applied a different adhesive to the incision. Patient had to stay in on the post op floor for two additional days for monitoring on post operative care floor, there are no samples to return. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-87825 |
| MDR Report Key | 9084175 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-18 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-08-16 |
| Date Mfgr Received | 2019-08-23 |
| Date Added to Maude | 2019-09-18 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| 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 22 SKIN CLOSURE SYSTEM |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-09-18 |
| Catalog Number | CLR222 |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-09-18 |