MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for RENASYS Y-CONNECTOR 66800971 manufactured by Smith & Nephew Medical Ltd..
[93420615]
Patient Sequence No: 1, Text Type: N, H10
[93420616]
It was reported that during treatment a y-connector was applied to a non-infected midline wound and a (b)(6) infected foot ulcer. Several days after, it was confirmed that the midline wound had (b)(6) infection.
Patient Sequence No: 1, Text Type: D, B5
[109156807]
Device was not evaluation due to the sample was not returned for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00301 |
| MDR Report Key | 7072930 |
| Date Received | 2017-11-30 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 28N |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 28N |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RENASYS Y-CONNECTOR |
| Generic Name | TUBE, ASPIRATING, FLEXIBLE, CONNECTING |
| Product Code | BYY |
| Date Received | 2017-11-30 |
| Catalog Number | 66800971 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 28N UK HU3 28N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-30 |