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 2019-12-30 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[185734499]
(b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. Was hemostasis achieved prior to the application of prineo? Was any oozing noted prior to the application of prineo? 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? What is the physicians opinion of the contributing factors? Patient demographics: initials / id; age or date of birth; bmi, patient pre-existing medical conditions (ie. Allergies, history of reactions). Patient current condition. 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
[185734500]
It was reported a patient underwent total hip arthroplasty on an unknown date and topical skin adhesive was used. The patient was treated with antibiotics prescribed as a precaution in case of infection. The adhesive was removed 10 days post op, per usual protocol. Patient was brought back for debridement/wash-out after being seen 10 days post-op. Soft tissue turned black along incision and out of precaution to preserve implants the surgeon completed the secondary procedure. Patient is now fine. No implants were removed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-91257 |
| MDR Report Key | 9531841 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-30 |
| Date of Report | 2019-12-04 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2019-12-30 |
| 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 | 2019-12-30 |
| Model Number | CLR222US |
| Catalog Number | CLR222US |
| 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 | 2019-12-30 |