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 2020-03-12 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[188629174]
(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. Additional information was requested and the following was obtained: what was the name of the procedure? -used in almost all breast and abdominal procedures so this is not just an exclusive reaction in one patient and one procedure. Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? There is no relevance to use of antibiotics as each patient gets a perioperative dose. Were prescription steroids administered? What medical/surgical intervention was provided? What is the current condition of the patient? Please describe in more detail "upon second use"? The reaction to the glue is in most cases developing around 5 days after application and causing intense itch redness and at times blistering exactly around the site of glue application. In some individuals they have undergone a reconstructive procedure in the past and prineo has been applied, however when they return 1 or 2 years to finalise their reconstruction, they are reacting to the glue. We have resorted in prescribing betnovate ointment and piriton , and only upon removal of the glue does the reaction settle after around 2 days. I have photographic evidence of the reaction. The single complaint was reported with multiple events. There are no additional details regarding the additional patient events. Attempts will be made to obtain additional information. If further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[188629175]
It was reported that the patient underwent an unknown procedure on an unknown date and topical skin adhesive was used. Upon second use of the device when patient returns 1 or 2 years to finalize reconstruction procedure, the patient is reacting to the device and required immediate attention. The reaction to the device developed in around 5 days after application and caused intense itch redness and at times blistering exactly around the site of glue application. The patient was prescribed betnovate ointment and piriton. It was reported that only upon removal of the glue does the reaction settle after around 2 days. Additional information will be requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01986 |
| MDR Report Key | 9824953 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-12 |
| 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 Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2020-03-12 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |