MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-23 for ENDOFORM DERMAL TEMPLATE 529311 manufactured by Aroa Biosurgery Ltd..
[142817762]
Aroa biosurgery became aware of a patient-reported event #mw5084906 via the company's us agent. Aroa initiated a voluntary recall (z-0377-2019, z-0378-2019 and z-0379-2019) in november 2018 as a preventive measure resulting from issues observed during internal in-process dye penetration testing of edt pouches. To-date there have been no reports or confirmation of seal integrity issues with any devices in the nine (9) recalled lots, thus no impact to the sterility of those devices. Endoform end-users (patients) receive frequent (e. G. Daily to weekly) dressing changes, wound assessment and necessary medical intervention. The health hazard evaluation conducted by a leading wound care clinical expert concluded that given the high rates of bacterial colonization typically associated with chronic wounds, and existing medical practices to reduce or control infection it is unlikely that application of a non-sterile device would result in any additional medical intervention not already being undertaken for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007321028-2019-00004 |
| MDR Report Key | 8541730 |
| Report Source | OTHER |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-03-30 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TINA O'BRIEN |
| Manufacturer Street | 2 KINGSFORD SMITH PLACE |
| Manufacturer City | AIRPORT OAKS, AUCKLAND 2022, |
| Manufacturer Country | NZ |
| Manufacturer G1 | AROA BIOSURGERY LTD. |
| Manufacturer Street | 2 KINGSFORD SMITH PLACE |
| Manufacturer City | AIRPORT OAKS, AUCKLAND 2022, |
| Manufacturer Country | NZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOFORM DERMAL TEMPLATE |
| Generic Name | COLLAGEN WOUND DRESSING |
| Product Code | KGN |
| Date Received | 2019-04-23 |
| Model Number | 529311 |
| Catalog Number | 529311 |
| Lot Number | EDT 7L01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AROA BIOSURGERY LTD. |
| Manufacturer Address | 2 KINGSFORD SMITH PLACE AIRPORT OAKS, AUCKLAND 2022 NZ 2022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |