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 2019-10-07 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[161698079]
(b)(4). Attempts were made to obtain the following additional information, however not received to date. Is a photo available of the blister/reaction? Date of surgery? Date of reaction? Describe the reaction (e. G. Blister/red/infected/mild? ). What specific type of medical / surgical treatment was provided to treat the reaction? 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? What is the current condition of the patient? 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
[161698080]
It was reported a patient underwent a total knee replacement on an unknown date and topical skin adhesive was used. Post-operatively, the patient experienced a severe allergic reaction and had to undergo plastic surgery to repair skin tissue damage. No device is available for return. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88412 |
| MDR Report Key | 9162127 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-07 |
| Date of Report | 2019-09-09 |
| Date Mfgr Received | 2019-09-09 |
| Date Added to Maude | 2019-10-07 |
| 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 | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 22CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-10-07 |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-07 |