MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for ENDOFORM DERMAL TEMPLATE manufactured by Aroa Biosurgery Ltd..
[137364747]
I have used endoform dermal templates on my chronic leg wounds since 2016. I was in a car accident many years ago and am left with open wounds on my lower legs that must remain sterile. In (b)(6) 2018 i developed a progressive deterioration in and around the wounds while still using this product. An infection began to spread outward, turning yellow and black with thick colored seepage. I was placed on oral antibiotics for a month and now i am on topical antibiotics. The wounds themselves have tripled in size and doctors have been unable to contain the spreading. I have now received a recall for the same products i have been placing on my chronic wounds. Aroa biosurgery ltd. Has issued a statement saying there is a quality control problem with potential pouch seal integrity rendering the product non-sterile, dating back to march 2018. I therefore have been putting non-sterile bandages on my open chronic wounds for months. Frequency? Daily. How was it taken or used? Topical. Why was the person using the product? (such as what condition was it supposed to treat) chronic leg wounds. Therapy duration? 3 year.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084390 |
| MDR Report Key | 8371833 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-23 |
| Date of Event | 2018-05-01 |
| Date Added to Maude | 2019-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-02-26 |
| Lot Number | EDT-7H06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AROA BIOSURGERY LTD. |
| Brand Name | ENDOFORM DERMAL TEMPLATE |
| Generic Name | DRESSING, WOUND, COLLAGEN |
| Product Code | KGN |
| Date Received | 2019-02-26 |
| Lot Number | EDT-7L02 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ARORA BIOSURGERY LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2019-02-26 |