MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-19 for DERMABOND UNKNOWN PRODUCT manufactured by Ethicon Inc..
[185944074]
(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. Please verify the product and event information for accuracy. How are you feeling? Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? If so, please provide your surgeon? S name, contact email information to provide authorization to use or disclose information. 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
[185944075]
It was reported a patient underwent a knee replacement surgery on (b)(6) 2020 and topical skin adhesive was used. On day three post op, the patient began having reaction symptoms: hives, itching, hot to the touch skin. These symptoms are localized but are spreading. She is afebrile. Her surgeon prescribed her oral prednisone. She currently has not taken systemic antihistamines-only topical aloe and cream at this point. They are trying to schedule an appointment with a dermatologist. No device will be returned. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01299 |
| MDR Report Key | 9730220 |
| Report Source | CONSUMER |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-19 |
| 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 UNKNOWN PRODUCT |
| Generic Name | ADHESIVE, TOPICAL SKIN |
| Product Code | MPN |
| Date Received | 2020-02-19 |
| 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 | 2020-02-19 |