MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-26 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[186547237]
(b)(4). Attempts to obtain the following information has been performed and the following was received. If the further details are received at a later date a supplemental medwatch will be sent. When was the dehiscence diagnosed? Intra-op or post-op? Dihiscence post-op in phase 2 recovery please advise of date of initial procedure. Date of procedure (b)(6) 2020 was prineo used during initial procedure? Prineo used at time of procedure? What date post op was wound dehiscence noted? (b)(6) 2020. If prineo used during initial procedure, what was the state of the prineo upon noting dehiscence? Don? T know. Were anomalies mentioned about mesh patch observed during initial procedure? Don? T know. Or post op while addressing dehiscence? Don? T know. Photo of dehiscence? No picture. Was there any other treatment provided (product removed; reoperation; prescription steroids; antibiotics prescribed) in addition to more adhesive? If so, please clarify don? T know. Please indicate any medical or surgical interventions performed. None. Was patient placed under anesthesia to address dehiscence? No. Please describe how was the adhesive was applied. Don? T know. What prep was used prior to, during or after prineo use? Chloroprep. Was a dressing placed over the incision? If so, what type of cover dressing used? Opsite 4x4? S. What is the surgeon? S opinion of the dehiscence and why it may have occurred? Don? T know. 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
[186547238]
It was reported a patient underwent an circumferential belt lipectomy on (b)(6) 2020 and topical skin adhesive was used. During phase 2 recovery in post op, the patient had some dehiscence. They applied more adhesive. Case completed with another device of the same product code. No device will be returned. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02384 |
| MDR Report Key | 9884016 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 Country | * |
| 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 | 2020-03-26 |
| Model Number | CLR222US |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |