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 2018-05-15 for NOVAPASS REVERDIN SUTURE PASSER C-PAS-30-11.4 manufactured by Cook Inc.
[108352163]
Patient code: blood loss selected for "bleeding" is not labeled; no code available selected for "required intervention". Device code: no known device issues reported. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[108352164]
It was reported that the device was used for trans-facial sutures with superior and inferior midline fixation points and 3 lateral fixation points. No perioperative bleeding was noted was reported. However, the patient had to returned to theatre post operatively to control bleeding into the rectus muscle. The surgeon believes the bleeding was due to using the reverdin novapass for the transfascial sutures. Questions were asked about the patient and the event. At this time, no further details regarding the patient or event have been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01469 |
| MDR Report Key | 7516450 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-15 |
| Date of Report | 2018-08-09 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-05-15 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVAPASS REVERDIN SUTURE PASSER |
| Generic Name | GEJ CARRIER, LIGATURE |
| Product Code | GEJ |
| Date Received | 2018-05-15 |
| Catalog Number | C-PAS-30-11.4 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-15 |