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 2019-11-27 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..
[168619296]
Product complaint # (b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: please describe how was the adhesive was applied. Put on top of the closed wound as per ifu. What prep was used prior to, during or after prineo use? Prep used prior to case. Was a dressing placed over the incision? If so, what type of cover dressing used? Yes. Dressing was placed on top for a few days. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? No. Is the patient hypersensitive to pressure sensitive adhesives? No. Were any patch or sensitivity tests performed prior to use? No. What is the physicians opinion of the contributing factors to the reaction? Not provided what is the most current patient status? Not provided. Patient demographics: initials / id; age or date of birth; bmi; initials (b)(6); dob: (b)(6); male. Was prineo / demabond or skin adhesive used on the patient in a previous surgery or wound closure? Unknown.
Patient Sequence No: 1, Text Type: N, H10
[168619297]
It was reported that a (b)(6) yr old male patient underwent a spinal procedure for decompression l3/4, l4/5 and l5/s1 on (b)(6) 2019 and topical skin adhesive was used. It was reported that the patient had a small reaction to the topical skin adhesive. On (b)(6) 2019, the practice manager removed the dressing and the inflammation / reaction was noticed. The patient presented to gp and was given a topical steroid cream. On (b)(6) 2019 the patient has improved and was advised to wash well in shower. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90359 |
| MDR Report Key | 9384414 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-22 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2019-11-27 |
| 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 | 982 ROAD 183 KM 8.3, |
| Manufacturer City | SAN LORENZO |
| 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 | 2019-11-27 |
| Catalog Number | CLR222 |
| 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 | 2019-11-27 |