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 2020-03-18 for DERMABOND ADVANCED 0.7ML - 12EA ANX12 manufactured by Ethicon Inc..
[188986791]
Product complaint # (b)(4). Attempts to obtain the following information has been performed and the following was received. If the further details are received at a later date a supplemental medwatch will be sent. Photo of reaction? No photos are available. Date of surgery? No further information is available. Date of reaction? No further information is available. Was there any other treatment provided (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed) in addition to steroids? If so, please clarify. No further information is available. Please indicate any medical or surgical interventions performed. No further information is available. Please describe how was the adhesive was applied. No further information is available. What prep was used prior to, during or after dermabond advanced use? No further information is available. Was a dressing placed over the incision? If so, what type of cover dressing used? No further information is available. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? No further information is available. Is the patient hypersensitive to pressure sensitive adhesives? No further information is available. Were any patch or sensitivity tests performed? No further information is available. What is the physicians opinion of the contributing factors to the reaction? The surgeon said, ""there was no problem with the first use, but the second use caused inflammation, so antibodies may be formed. "" what is the most current patient status? No further information is available. Is the product lot available or representative sample (product from the same lot number) available for evaluation? No sample will be returned. Patient demographics: initials / id; age or date of birth; bmi ; no further information is available. Patient pre-existing medical conditions (ie. Allergies, history of reactions) no further information is available. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? No further information is available. 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
[188986792]
It was reported a patient underwent a pneumothorax procedure on an unknown date and topical skin adhesive was used. Dermatitis was observed on the patient. This was the 2nd exposure of adhesive to the patient. The product was peeled off at the discretion of the dermatologist. Steroids were administered to the patient. The surgeon said, "there was no problem with the first use, but the second use caused inflammation, so antibodies may be formed. " further details are not provided. No sample will be returned. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02211 |
| MDR Report Key | 9849950 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-18 |
| 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 ADVANCED 0.7ML - 12EA |
| Generic Name | ADHESIVE, TOPICAL SKIN |
| Product Code | MPN |
| Date Received | 2020-03-18 |
| Catalog Number | ANX12 |
| 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 | 2020-03-18 |