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 2019-10-16 for PRINEO 22 SKIN CLOSURE SYSTEM CLR222US15 manufactured by Ethicon Inc..
[166809564]
(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. Date of surgery? Date of reaction? Describe the reaction (e. G. Blister/red/infected/mild). It was noted that topical steroids were administered. What if any other specific type of medical / surgical treatment was provided to treat the reaction? Please clarify/specify which adverse event was experienced in the statement: did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? Yes. 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) it was noted prineo was used for prior right hip replacement surgery. Was the patient exposed to similar products, such as artificial nails?
Patient Sequence No: 1, Text Type: N, H10
[166809565]
It was reported that the patient underwent left total hip replacement surgery on an unknown date and topical skin adhesive was used. The patient experienced allergic reaction and dermatitis. The patient was administered topical steroids. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88749 |
| MDR Report Key | 9199573 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-16 |
| Date of Report | 2019-09-21 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-10-16 |
| 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 | PRINEO 22 SKIN CLOSURE SYSTEM |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-10-16 |
| Catalog Number | CLR222US15 |
| 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 | 2019-10-16 |