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 2019-10-07 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..
[161701315]
(b)(4). The following additional information was requested and received: is a photo available of the reaction? A photo. Specific date in august of cabg surgery? (b)(6) 2019. Describe the reaction (e. G. Blister/red/infected/mild? ) slight redness was observed on the skin immediately after the product was removed. Then redness expanded. Redness occurred in both the midline chest incision site and the lower limb wound. Redness expands about 10 cm above and below the wound. What other medical / surgical treatment was provided to treat the reaction? Linderon was administered, but it was changed to azunol ointment since the patient had a feeling of heat. At the same time, allelock was administered. What prep was used prior to, during or after prineo use? No further information is available. How many layers of adhesive were used over during application? No further information is available. Was a dressing placed over the incision? If so, what type of cover dressing used? No further information is available. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? No further information is available. What is the physicians opinion of the contributing factors to the reaction? The doctor commented that i don't know the possible causes other than dermabond. Patient demographics: initials / id; age or date of birth; bmi, the patient is male. Patient pre-existing medical conditions (ie. Allergies, history of reactions) no further information is available. Was the patient exposed to similar products? No further information is available. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? No further information is available. The single complaint was reported with multiple events. There are no additional details regarding the additional patient events. Attempts are being made to obtain the following information it was noted that the surgeon experienced slight reddening cases: please advise if these events were reported previously? No further information is available. How many patient events occurred? No further information is available. Provide details of each event (description, surgery type, date? ) and create files to capture. No further information is available. No further information will be provided. To date no samples are available. 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
[161701316]
It was reported a patient underwent a cabg surgery on an unknown date in (b)(6) 2019 and topical skin adhesive was used. The adhesive was used on the midline chest incision site wound. 1 week after the surgery, when removing the mesh patches, slight reddening occurred around the wounds, then the reddening started spreading the next day. Contact dermatitis occurred. Linderon was administered, but it was changed to azunol ointment since the patient had a feeling of heat. At the same time, allelock was administered. Since then, the symptom has been improving. The hospitalization period was extended for 1 week. The patient was discharged from the hospital. The lot number is unknown. Further details are not provided. No sample will be returned. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88413 |
| MDR Report Key | 9163057 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-07 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-09-10 |
| Date Added to Maude | 2019-10-07 |
| 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 | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 22CM MSH 3.8ML ADHESIVE |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-10-07 |
| Catalog Number | CLR222US |
| 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 | 2019-10-07 |