MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-30 for RENASYS TOUCH DEVICE & POWER SUP 66801280 manufactured by Smith & Nephew Medical Ltd..
[168623762]
It was reported that the renasys touch pump was alarming canister full despite new dressing and canister were used. The therapy stopped for several hours until the backup device was provided to continue therapy. There was no patient harmed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8043484-2019-00875 |
MDR Report Key | 9392637 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-30 |
Date of Report | 2019-11-30 |
Date of Event | 2019-11-05 |
Date Mfgr Received | 2019-11-05 |
Date Added to Maude | 2019-11-30 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | DR. SARAH FREESTONE |
Manufacturer Street | 101 HESSLE ROAD |
Manufacturer City | HULL HU3 2BN |
Manufacturer Country | UK |
Manufacturer Postal | HU3 2BN |
Manufacturer Phone | 0447940038 |
Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
Manufacturer Street | 101 HESSLE ROAD |
Manufacturer City | HULL HU3 2BN |
Manufacturer Country | UK |
Manufacturer Postal Code | HU3 2BN |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RENASYS TOUCH DEVICE & POWER SUP |
Generic Name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Product Code | OMP |
Date Received | 2019-11-30 |
Returned To Mfg | 2019-11-22 |
Catalog Number | 66801280 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
Manufacturer Address | 101 HESSLE ROAD HULL UK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-30 |