MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-09 for DERMABOND HV 0.5ML VIAL - 12EA AHV12 manufactured by Ethicon Inc..
[186291407]
(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 have been made and no response to date. If further details or the device are received at a later date a supplemental medwatch will be sent. Are any photos of wound available? Initial wound laceration closure date? Please confirm, it was noted the reaction and dehiscence occurred post op day 5 on (b)(6) 2020? How was the reaction / dehiscence treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? If so, please clarify. Please indicate any medical or surgical interventions performed. Please describe how was the adhesive was applied on the tape. What prep was used prior to, during or after dermabond advanced use? 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? Is the patient hypersensitive to pressure sensitive adhesives? Were any patch or sensitivity tests performed? Do you have the product lot number involved? What is the physicians opinion of the contributing factors to the reaction? 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 or date of birth; bmi; 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? 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
[186291408]
It was reported a patient underwent an laceration closure in emergency department on (b)(6) 2020 and topical skin adhesive was used. 5 days later, patient visited resident surgeon to change dressings. Wound dehiscence and massive secretion with vesicles and slight reddening was found. Not typical symptoms for infection. Development of large contact dermatitis. Treatment is still ongoing. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01847 |
| MDR Report Key | 9808181 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-11-05 |
| Date Added to Maude | 2020-03-09 |
| 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 HV 0.5ML VIAL - 12EA |
| Generic Name | ADHESIVE, TOPICAL SKIN |
| Product Code | MPN |
| Date Received | 2020-03-09 |
| Catalog Number | AHV12 |
| Lot Number | MMR919 |
| 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 | 2020-03-09 |