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 2019-12-17 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..
[188031967]
Product complaint # (b)(4). Sent to the fda. Attempts to obtain the following information have been made, no response has been received to date. 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. What type of topical steroids were administered? What if any other specific type of medical / surgical treatment was provided to treat the reaction? 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? Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? What is the physicians opinion of the contributing factors to the reaction? Patient demographics: initials / id; age or date of birth; bmi, weight? Patient pre-existing medical conditions (ie. Allergies, history of reactions) it was noted prineo was used for prior total knee. Was reaction reported?
Patient Sequence No: 1, Text Type: N, H10
[188031968]
It was reported a patient underwent a total knee replacement on an (b)(6) 2019 and topical skin adhesive was used. The adhesive was applied into the entire incision length. Patient developed an allergic reaction to adhesive on (b)(6) 2019. The entire mesh area and mesh edges was red and was very itchy. Doctor removed the mesh using saline, applied topical steroids and prescribed oral medication for patient on (b)(6) 2019. Redness subsided slightly by (b)(6) 2019, patient was discharged. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90996 |
| MDR Report Key | 9481875 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-17 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-11-23 |
| Date Mfgr Received | 2019-11-26 |
| Date Added to Maude | 2019-12-17 |
| 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 | DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-12-17 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-17 |