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 2020-03-09 for DERMABOND MINI HV 0.36ML VIAL - 12EA AHVM12 manufactured by Ethicon Inc..
[186305060]
Product complaint # (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. Please provide photos. Specific procedure name? Initial procedure date? What date did the lesion/occur, post op? What is the physicians opinion of the contributing factors to the reaction? How was the lesion 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. What prep was used prior to, during or after dermabond 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 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; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions) the analysis results found that the device was returned inside of the sterile packaging unopened. Upon visual inspection, the sample was observed to be conforming according to manufacturing specifications. If further details or the device are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[186305061]
It was reported a patient underwent an anterior aspect scalp lesion on (b)(6) 2019 and topical skin adhesive was used. This lesion developed aponeurosis ischaemia with bare bone exposed (it was described as if it had eaten into it). Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01845 |
| MDR Report Key | 9806997 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-09 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-02-09 |
| Device Manufacturer Date | 2019-06-20 |
| 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 Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMABOND MINI HV 0.36ML VIAL - 12EA |
| Generic Name | ADHESIVE, TOPICAL SKIN |
| Product Code | MPN |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-03-03 |
| Catalog Number | AHVM12 |
| Lot Number | PGJ444 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 |