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 2019-09-18 for DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE CLR602US manufactured by Ethicon Inc..
[160720482]
Product complaint # (b)(4). The following additional information was requested, however no response has been received to date: are photos available of the reaction? Date of surgery? What date did the reaction occur post op? Lot number? Describe the reaction (e. G. Blister/red/infected/mild? ) was any other medical / surgical treatment provided to treat the reaction, in addition to the antibiotics? What prep was used prior to, during or after prineo use? How many layers of adhesive were used over during application? 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? What is the physicians opinion of the contributing factors to the reaction? Patient demographics: initials / id; age or date of birth; bmi patient pre-existing medical conditions (ie. Allergies, history of reactions) was the patient exposed to similar products, such as artificial nails? 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 and the additional information has not been received. 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
[160720483]
It was reported a patient underwent a breast reduction on an unknown date and topical skin adhesive was used. Post operatively, the patient had an allergic reaction to the product. The surgeon stated that it was light pink around the breast area. The patient was given antibiotics. The product was removed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-87805 |
| MDR Report Key | 9083122 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-18 |
| Date of Report | 2019-08-23 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2019-09-18 |
| 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 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| 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 PRINEO 60CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-09-18 |
| Catalog Number | CLR602US |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-18 |