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 2019-12-10 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..
[185480690]
(b)(4). 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. 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. How was the wound reaction managed? How was the reaction treated (prescription steroids; antibiotics prescribed)? Please describe how was the adhesive applied on the tape. What prep was used prior to, during or after prineo use? 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 ; gender. 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?
Patient Sequence No: 1, Text Type: N, H10
[185480691]
It was reported that the patient underwent total knee replacement on (b)(6) 2019 and topical skin adhesive was used. Post-operatively, the patient experienced a skin reaction at the surgical site aligned with the topical skin adhesive. The patient was re-admitted to manage wound reaction and superficial site infection risk. The patient experienced mild blisters and inflammation. The topical skin adhesive was removed and patient received wound reaction management. The surgeon opined they do not believe the patient experienced a true topical skin adhesive reaction and much of the redness was pink prep left under the topical skin adhesive. Following immediate removal of the topical skin adhesive, the patient progress was reported as very well. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90728 |
| MDR Report Key | 9445556 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-10 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2019-12-10 |
| 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 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 | 2019-12-10 |
| Model Number | CLR222 |
| Catalog Number | CLR222 |
| 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 | 2019-12-10 |