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 2019-09-24 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..
[159894295]
(b)(4). The following additional information has been requested but no response received to date: the following additional questions have been sent to bq: what was the initial spine procedure date? What post op date did the infection occur? What medical / surgical treatment was provided to treat the infection? Patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? Were there any pre-existing signs / symptoms of active infection prior to this surgical procedure? Were cultures performed? If so, what are the results? Do you have any photos? Did the patient receive any prophylactic antibiotics pre-, intra- or post-procedure? Please describe where was the adhesive was applied on the patient? Please describe how was the adhesive applied on patient? What prep was used prior to, during or after prineo use? Was a dressing placed over the wound? If so, what type of cover dressing used? What is the physicians opinion of the contributing factors to the reaction? What is the most current patient status? To date the device has not been returned. 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
[159894296]
It was reported a patient underwent a minimally invasive spine discectomy on (b)(6) 2019 and topical skin adhesive was used. Post operatively, the patient developed an infection and surgical intervention was performed on (b)(6) 2019. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-88041 |
| MDR Report Key | 9111528 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-24 |
| Date of Report | 2019-08-30 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2019-09-24 |
| 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 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| 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 | 2019-09-24 |
| Catalog Number | CLR222 |
| Lot Number | MGH756 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-24 |