MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-05 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[166817843]
(b)(4). Attempts to obtain the following additional information have been made. No response to date. The device have been made with no return to date. If the device or further details are received at a later date a supplemental medwatch will be sent. Please provide photos. 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? Were any patch or sensitivity tests performed? 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? Patient demographics: initials / id; age or date of birth; bmi; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions).
Patient Sequence No: 1, Text Type: N, H10
[166817844]
It was reported a patient underwent a breast implant exchange and mastopexy on (b)(6) 2019 and topical skin adhesive was used. The patient had a reaction to adhesive: contact dermatitis, rash with blistering on bottom of each breast where dermabond applied, lateral chest and abdomen. The adhesive was removed, followed by prescription steroids and prescription steroid cream. Patient referred to dermatologist. Initial rash is getting better but not resolved. The product code and lot number are unknown. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-89510 |
| MDR Report Key | 9279620 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-05 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-10-04 |
| Date Mfgr Received | 2019-10-17 |
| Date Added to Maude | 2019-11-05 |
| 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 |
| Manufacturer Country | US |
| 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 | 2019-11-05 |
| Catalog Number | UNK |
| 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 | 2019-11-05 |