MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-10 for TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE N/A TPSS100 manufactured by Dornoch.
[141485622]
(b)(4). Once the investigation is complete, a follow-up mdr will be submitted. Device evaluated by external contractor.
Patient Sequence No: 1, Text Type: N, H10
[141485623]
It was reported that the transposal safety station right side canister ring was broken and wire was exposed. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001954182-2019-00025 |
| MDR Report Key | 8500260 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2016-02-04 |
| Date Added to Maude | 2019-04-10 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | DORNOCH |
| Manufacturer Street | 200 NORTHWEST PARKWAY |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64150 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2019-04-10 |
| Model Number | N/A |
| Catalog Number | TPSS100 |
| Lot Number | 0021573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH |
| Manufacturer Address | 200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |