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 2019-12-17 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[171561684]
Product complaint # (b)(4). Attempts to obtain the following information have been made, no response has been received to date. 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. Is a photo available of the reaction? Describe the reaction (e. G. Blister/ red/ infected/ mild)? Were there any pre-existing signs/ symptoms of active infection prior to this surgical procedure? Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? Were cultures performed? Results? What medical intervention and or treatment was performed to address the reaction/infection? Results? 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/ infection? Patient demographics: initials / id; gender, 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? Does the surgeon believe there was any deficiency with the stratafix suture used subcuticular? What is the surgeon opinion of the relationship of the stratafix suture to the reaction/ infection? What is the most current patient status? It was noted that the surgeon experienced? Many times? : please advise if these events were reported previously? How many patient events occurred? Provide details of each event (description, surgery type, date) and create files to capture. Related adverse events captured in reports: 2210968-2019-90972, 2210968-2019-90973. 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.
Patient Sequence No: 1, Text Type: N, H10
[171561685]
It was reported a patient underwent a total knee replacement on (b)(6) 2019 and topical skin adhesive was used. After the subcuticular closure with barbed suture for the skin, the adhesive was applied on the incision after it was cleaned and dried and the patient was discharged. When the patient came back to check the wound, the surgeon found that the wound was red and infected. The surgeon thinks it's because of the adhesive as the skin reaction of the wound takes the shape of the adhesive. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90972 |
| MDR Report Key | 9477765 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-17 |
| Date of Report | 2019-11-24 |
| Date of Event | 2019-11-09 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2019-12-17 |
| 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 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 | 2019-12-17 |
| Catalog Number | CLR222US |
| Lot Number | PAH896 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-17 |