MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-11-28 for TRAUMA IMPLANT manufactured by Smith & Nephew, Inc..
[168432095]
It was reported that the patient participated in a (b)(6) study, after surgery the patient developed infection and needed surgical debridement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1020279-2019-04194 |
MDR Report Key | 9390496 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
Date Received | 2019-11-28 |
Date of Report | 2019-11-28 |
Date Mfgr Received | 2019-11-06 |
Date Added to Maude | 2019-11-28 |
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 | DR. SARAH FREESTONE |
Manufacturer Street | 1450 BROOKS ROAD |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal | 38116 |
Manufacturer Phone | 0447940038 |
Manufacturer G1 | SMITH & NEPHEW, INC. |
Manufacturer Street | 1450 BROOKS ROAD |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal Code | 38116 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TRAUMA IMPLANT |
Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code | MDM |
Date Received | 2019-11-28 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITH & NEPHEW, INC. |
Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-28 |