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 2019-10-02 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[161004665]
(b)(4). The following additional information has been requested however not received to date: initial date of tkr? It was noted that 3 weeks post op the wound dehiscenced, what was the date? Was the prineo in place at the time of the dehiscence? What medical / surgical treatment was provided to treat the dehiscence? Lot number? What prep was used prior to, during or after prineo use? How many layers of adhesive were used over during application? Was a dressing placed over the incision? If so, what type of cover dressing used? What is the physicians opinion of the contributing factors to the dehiscence? Patient demographics: initials / id; age or date of birth; bmi. The following response has been obtained: no further information has been provided other than nurse practitioner commenting this was a non-compliant patient during post operative recovery and also again when readmitted from skilled nursing facility. 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
[161004666]
It was reported a patient underwent a total knee replacement procedure on an unknown date in (b)(6) 2019 and topical skin adhesive was used. Patient was readmitted from a skilled nursing facility with a wound dehiscence, three weeks post operatively. Unknown if adhesive was still on at time of admission. Patient has history of anxiety and alcohol abuse. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88298 |
| MDR Report Key | 9145344 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-09-04 |
| Date Added to Maude | 2019-10-02 |
| 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 | 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 | DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-10-02 |
| Catalog Number | CLR222US |
| 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. Required No Informationntervention | 2019-10-02 |