MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-10-08 for DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE CLR602 manufactured by Ethicon Inc..
[169060163]
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. The following additional information was requested and received: is a photo available of the blister/reaction? Not available. Name of surgery? Caesarea. Date of surgery? Not available. Describe the reaction (e. G. Blister/red/infected/mild? ) allergic reaction. What specific type of medical / surgical treatment was provided to treat the reaction? Increased hospitalization, antibiotic, product lookup and handling of infected wounds. What prep was used prior to, during or after prineo use? Surgical wound asepsis. How many layers of adhesive were used over during application? Unknown. Was a dressing placed over the incision? If so, what type of cover dressing used? Unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? Unknown. What is the physicians opinion of the contributing factors to the reaction? The patient made allergic reaction to the product. Patient demographics: initials / id; age or date of birth; bmi: unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions): unknown. Was the patient exposed to similar products, such as artificial nails? Unknown. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? No, first time it's been used on the patient. To date no sample has been returned. If product is returned or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[169060164]
It was reported a patient underwent a cesarean section on an unknown date and topical skin adhesive was used. The patient presented with blister, erythema, allergic skin reaction and burning at the site. The patient received treatment with prescription antibiotic, increased hospitalization and handling of infected wounds. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88447 |
| MDR Report Key | 9167541 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-10-08 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-09-11 |
| Date Mfgr Received | 2019-09-12 |
| Device Manufacturer Date | 2018-09-05 |
| Date Added to Maude | 2019-10-08 |
| 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 60CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-10-08 |
| Catalog Number | CLR602 |
| Lot Number | MKR871 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-10-08 |