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 2020-03-03 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[186369035]
Product complaint # (b)(4). 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 clarify: how many patient events and details surrounding each for complaint reporting, or if no additional information is available. And what complaints do the 2 patient photos correspond with and/or is it of the same patient? Photo of reaction? Name of surgery? Date of surgery? Date of reaction? Was there any other treatment provided (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 prineo 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? 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? The single complaint was reported with multiple events. There are no additional details regarding the additional patient events. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. 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
[186369040]
It was reported a patient underwent an orthopedic procedure on an unknown date and topical skin adhesive was used. The patient had a skin reaction / irritation which occurred about two weeks after application. After reaction, adhesive was removed. Systemic rash appeared on lower extremities, not upper. The patient was prescribed steroid. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01684 |
| MDR Report Key | 9779181 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-03 |
| 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 PRINEO 22CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2020-03-03 |
| Model Number | CLR222US |
| Catalog Number | CLR222US |
| 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 | 2020-03-03 |