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 2019-09-24 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[162975242]
Product complaint # (b)(4). The following additional information was requested and obtained: what does the reaction look like and how large of an area does the reaction cover? After further investigation the reaction that the doctor was experiencing was not a chemical reaction. The surgeon experienced oozing of blood and slight dehiscence. I will discuss some homeostasis products to address this issue. Do you have any pictures of the reaction? No. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? If so, please clarify. N/a. What is the most current patient status? The doctor changed the patients dressing with something other than prineo. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? N/a. The following additional information has been requested but no response received to date: what date did the reaction / dehiscence occur post op? What medical / surgical treatment was provided to treat the dehiscence? What medical / surgical treatment was provided to treat the reaction? Lot number? Describe the reaction (e. G. Blister/red/infected/mild) 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, gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? What was the patient outcome? 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
[162975243]
It was reported a patient underwent a total hip replacement procedure on (b)(6) 2019 and topical skin adhesive was used. Post operatively, the patients developed bumps and skin reactions, wound dehiscence and discharge. The doctor changed the patients dressing with something other than adhesive. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88035 |
| MDR Report Key | 9111294 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-24 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2019-09-24 |
| 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 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| 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 | 2019-09-24 |
| Catalog Number | CLR222US |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-24 |