MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-07 for TISSUEGLU manufactured by Cohera Medical.
[69502096]
Caller stated during pre-op for her tummy tuck a manufacturer representative convinced her to use a tissue adhesive free of charge to seal her surgical wound site. Since the surgery, the caller has had multiple abscesses at her wound site and upper abdomen, abdominal pain, multiple infections, and general inflammation. The surgeon found the adhesive did not close and dissolve into surgical site as intended, instead it fragmented into tiny clumps of which he was unable to remove. The caller attempted to contact the manufacturer on several occasions but has not received any responses. She is currently scheduled to have another procedure to remove more of the adhesive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068317 |
| MDR Report Key | 6386815 |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-07 |
| Date of Event | 2015-11-01 |
| Date Added to Maude | 2017-03-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TISSUEGLU |
| Generic Name | ADHESIVE |
| Product Code | PJK |
| Date Received | 2017-03-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COHERA MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-07 |