MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for ENDOFORM DERMAL TEMPLATE manufactured by Aroa Biosurgery Ltd..
[138949420]
Blister on toe. Visit to doctor in (b)(6) (b)(6) 2018. Prescribed endoform dermal template (aroa biosurgery) - received (b)(6) 2018, used as prescribed. Wound worsened and developed odor - bone visible. Saw doctor in (b)(6) (b)(6) 2018, ordered cat scan. Reviewed with doc the results of cat scan. Visited foot orthopedic surgeon. Test showed bone infection. Agreed to toe amputation (b)(6) 2018. Surgery to remove infected toe (b)(6) 2019. (b)(4) medical products. Strength: 2" x 2'. Quantity: 1 small piece. Frequency: daily. How was it taken or used? On skin. Date the person first started taking or using the product: (b)(6) 2018. Date the person stopped taking or using the product: (b)(6) 2018. Why was the person using the product? Blister on toe #2, left foot. Did the problem stop after the person reduced the dose or stopped taking or using the product? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084906 |
| MDR Report Key | 8420709 |
| Date Received | 2019-03-13 |
| Date Added to Maude | 2019-03-14 |
| 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 | ENDOFORM DERMAL TEMPLATE |
| Generic Name | DRESSING, WOUND, COLLAGEN |
| Product Code | KGN |
| Date Received | 2019-03-13 |
| Lot Number | EDT 7L01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AROA BIOSURGERY LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-03-13 |