MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-11 for TISSUGLU SURGICAL ADHESIVE TG100US manufactured by Cohera Medical Inc.
[97050835]
It was reported to the company by dr. (b)(6) that a patient underwent abdominoplasty surgery using tissuglu surgical adhesive in conjunction with standard of care on (b)(6) 2017. On (b)(6) 2017, the surgeon reported that the patient had presented with a skin rash in the area of treatment and requested information about the potential for an allergic reaction to tissuglu. On (b)(6) 2018, the company received additional information from dr (b)(6) that the patient's condition had included redness/irritation, with no fever, normal edema, and some mild swelling. Its was reported that the patient was treated on (b)(6) 2017 with keflex and medrol and the redness in the area resolved within a short time. Dr. (b)(6) alleges that the redness/irritation was probably resolved by the medrol. The swelling was treated by the physician as normal seroma which is an expected complication associated with abdominoplasty surgical procedures. On (b)(6) 2018 the patient was reported, by dr. (b)(6), to be in good health and required no additional procedures after the initial action on (b)(6) 2017. The potential for allergic reaction to tissuglu? Surgical adhesive is stated in the directions for use for the product as a known potential complication. .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012970114-2018-00001 |
| MDR Report Key | 7183869 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2017-02-07 |
| Date Added to Maude | 2018-01-11 |
| 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 | 2018-01-11 |
| Model Number | TG100US |
| Catalog Number | TG100US |
| Lot Number | CM0344 |
| Device Expiration Date | 2018-10-31 |
| Operator | PHYSICIAN |
| 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. Other | 2018-01-11 |