MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-21 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT PRINEOUNK manufactured by Ethicon Inc..
[163123986]
Product complaint # (b)(4). The following additional information was requested and received: how was the reaction treated (product removed; prescription steroids; antibiotics prescribed; reoperation; reclosure;)? If so, please clarify. The reaction was treated with oral steroids. Were any patch or sensitivity tests performed? Patch testing was not done (but will be). Patient demographics: initials / id; age or date of birth; bmi ; gender pg/age: (b)(6)/female. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure. I believe the product was used before. What is the most current patient status? Patient status is reaction is resolved. Please be advised that i do not have access to most of the information you are asking. Attempts have been made to obtain the following information, however not received to date. Initial procedure date. Please describe how was the adhesive applied on the tape. What prep was used prior to, during or after prineo use? 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? Patient pre-existing medical conditions (ie. Allergies, history of reactions). What is the physicians opinion of the contributing factors to the reaction? Is the product or representative sample (product from the same lot number) available for evaluation? To date the device has not been returned and all of the additional information requested has not been received. 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
[163123987]
It was reported a patient underwent an unknown procedure on an unknown date and topical skin adhesive was used. The patient has presented post operatively with a severe contact dermatitis reaction, additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88877 |
| MDR Report Key | 9214892 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-10-02 |
| Date Mfgr Received | 2019-10-03 |
| Date Added to Maude | 2019-10-21 |
| 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 SKIN CLOSURE SYSTEM UNKNOWN PRODUCT |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-10-21 |
| Catalog Number | PRINEOUNK |
| Device Availability | * |
| 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 | 2019-10-21 |