MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for NEOX 100 manufactured by Bio-tissue, Inc.
[56598006]
Patient Sequence No: 1, Text Type: N, H10
[56598007]
Two types of amniotic membrane graft materials manufactured by the same company with similar packaging. Product # 1 amniograft cryopreserved human amniotic membrane for ocular use and product #2 neox 100 cryopreserved human amniotic membrane wound matrix for dermal use. According to the company representative the products are essentially the same products marketed for different indications, one for wound care the other for ocular use. One contains ciprofloxacin the other does not. Both products with amphotericin b. Both products package labeling and package insert are similar in appearance. The package inserts and the package labeling are unclear. The neox 100 product was used instead of the amniograft product, the patient underwent a second procedure to remove and replace the graft with the one that was explicitly labeled for ocular use. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6003806 |
| MDR Report Key | 6003806 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-09 |
| Report Date | 2016-08-23 |
| Date Reported to FDA | 2016-08-23 |
| Date Reported to Mfgr | 2016-08-23 |
| Date Added to Maude | 2016-10-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | NEOX 100 |
| Generic Name | CRYOPRESERVED HUMAN AMNIOTIC MEMBRANE WOUND MATRIX |
| Product Code | LMO |
| Date Received | 2016-10-06 |
| Lot Number | KG14K026 |
| Device Expiration Date | 2017-07-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIO-TISSUE, INC |
| Manufacturer Address | 8305 NW 27TH ST STE 101 DORAL FL 33122 US 33122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-06 |