MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-18 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..
[186523761]
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Attempts to obtain the following information has been performed but not received. If the further details are received at a later date a supplemental medwatch will be sent confirm the initial procedure date was (b)(6) 2020? Was there any wound dehiscence? What is the physicians opinion of the contributing factors to the prineo coming off prematurely? How was the wound treated (product removed; re operation; re closure; prescription steroids; antibiotics prescribed)? If so, please clarify. Please indicate any medical or surgical interventions performed. Please describe how was the adhesive was applied. What prep was used prior to, during or after prineo use? Please describe the aquacel dressing? What is the most current patient status? Is the product or representative sample (product from the same lot number) available for evaluation? Patient demographics: initials / id; age; bmi; gender. 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
[186523762]
It was reported a patient underwent a total knee replacement on (b)(6) 2020 and topical skin adhesive was used. The surgeon placed adhesive. The wound was dry and the product was placed with no problems. There was additional dressing placed on top of adhesive (aquacel surgical). The day after surgery the product fell of and the surgeon had to suture the wound. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02198 |
| MDR Report Key | 9848628 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2020-03-18 |
| 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 | 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 | 2020-03-18 |
| Model Number | CLR222 |
| Catalog Number | CLR222 |
| Lot Number | MMQ177 |
| 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 | 2020-03-18 |