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 2019-12-11 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..
[170939451]
(b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. What other 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? Was the patient exposed to similar products, such as artificial nails? Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? Current status of patient? Related adverse events captured in reports: 2210968-2019-90742. 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
[170939452]
It was reported a patient underwent a bilateral anterior & lateral compartment fasciotomies on (b)(6) 2019 and topical skin adhesive was used. 2 weeks post op, reaction appeared. Patient removed dressing at home with warm water in the shower. Reporting a red rash under and around the edges of the adhesive. Prior to this patient reports no issues. Visited general practioner two days later as saw no improvement. General practioner commenced oral and topical steroids. Reaction improved. Oral steroids finished after 5 days. Patient continued on topical treatment. However no further improvement in wound area was reported, milder rash persisted. (b)(6) 2019 a new rash appeared on the patients thighs, progressing to 'welts' (b)(6) 2019. Pt still using topical steroid cream. Oral steroids started again on (b)(6) 2019 post ortho clinic visit. Clinic have recommended pt cease topical over this weekend to determine if unintentional steroid exposure to the thighs is causing the rash and welts. Patient booked to revisit clinic (b)(6) 2019 for follow-up review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90743 |
| MDR Report Key | 9449727 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-11 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2019-12-11 |
| 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 |
| 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 | 2019-12-11 |
| Catalog Number | CLR222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-11 |