MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-17 for TISSUGLU SURGICAL ADHESIVE TG100US manufactured by Cohera Medical, Inc.
[92460361]
It was reported to the company on (b)(6) 2017 that a patient who had underwent an abdominoplasty surgery using tissuglu? Surgical adhesive in conjunction with standard of care on (b)(6) 2017 had a minor complication on (b)(6) 2017. On (b)(6) 2017 the surgeon notified cohera medical that the patient had required a procedure to open a raised surface area, described as an abscess, along the incision line. On (b)(6) 2017 the raised surface area was opened, by the physician, using a minor procedure in the or and an alleged small amount of residual tissuglu? Surgical adhesive was removed using forceps. The reported condition on the abdomen can be a precursor to extrusion and therefore is consistent with known potential complications associated with abdominoplasty surgeries and is described as a precaution in the tissuglu surgical adhesive directions for use ((b)(4)): "consideration should be taken in the use of tissuglu? , as there is a possibility that cured tissuglu? May be extruded similar to suture extrusion. Further communication on (b)(6) 2017 between cohera and the physician and staff find that the patient's condition was resolved and required no additional intervention after the additional procedure performed on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012970114-2017-00004 |
| MDR Report Key | 7042163 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-10-19 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2017-11-17 |
| 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 | 2017-11-17 |
| Model Number | TG100US |
| Catalog Number | TG100US |
| Lot Number | CM0337 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-11-17 |