MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-15 for TISSUGLU SURGICAL ADHESIVE TG100US manufactured by Cohera Medical Inc.
[59967372]
It was reported to the company by a healthcare professional that a patient underwent an abdominoplasty surgery using tissuglu surgical adhesive in conjunction with standard of care on (b)(6) 2015. At an unknown date, the patient allegedly developed a small opening on her abdomen which discharged fluid and expelled piece(s) of cured tissuglu surgical adhesive. It was further reported that on (b)(6) 2016, the patient's surgeon conducted an additional surgical procedure to clean and close the abdominal opening. The patient is currently being treated for minor complications associated with the additional surgical procedure. The reported opening on the abdomen and extrusion of tissuglu surgical adhesive fragments is consistent with known potential complications associated with abdominoplasty surgeries and is described as a precaution in the tissuglu surgical adhesive directions for use (dfu-100-0001): "consideration should be taken in the use of tissuglu, as there is a possibility that cured tissuglu may be extruded similar to suture extrusion.
Patient Sequence No: 1, Text Type: D, B5
[71004679]
It was reported by a healthcare professional that the patient received follow-up treatment with respect to alleged continued complications associated with an abdominoplasty surgery using tissuglu(r) surgical adhesive in conjunction with standard of care. The healthcare professional prescribed antibiotics for the alleged complication on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006559785-2016-00001 |
| MDR Report Key | 6105061 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-15 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-19 |
| Device Manufacturer Date | 2016-05-02 |
| Date Added to Maude | 2016-11-15 |
| 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 CHRIS FERGUSON |
| Manufacturer Street | 227 FAYETTEVILLE ST SUITE 900 |
| Manufacturer City | RALEIGH NC 27601 |
| Manufacturer Country | US |
| Manufacturer Postal | 27601 |
| Manufacturer Phone | 9842220391 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUGLU SURGICAL ADHESIVE |
| Generic Name | TISSUGLU |
| Product Code | PJK |
| Date Received | 2016-11-15 |
| Model Number | TG100US |
| Lot Number | CM0332 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COHERA MEDICAL INC |
| Manufacturer Address | 227 FAYETTEVILLE ST SUITE 900 RALEIGH NC 27601 US 27601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-15 |