MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-12-13 for SAFHS 2000 MOU ASSEMBLY 71034014 manufactured by Smith & Nephew Orthopaedics.
[2446380]
It was reported that a mild to moderate skin irritation occurred which resulted in medical intervention. It is the primary treating physician's opinion that it is not serious, but is related to either the exogen unit or the ultrasound gel, as the irritation is the same shape as the transducer.
Patient Sequence No: 1, Text Type: D, B5
[9447946]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2011-00524 |
| MDR Report Key | 2369847 |
| Report Source | 08 |
| Date Received | 2011-12-13 |
| Date of Report | 2011-12-09 |
| Date of Event | 2011-09-16 |
| Date Mfgr Received | 2011-12-09 |
| Device Manufacturer Date | 1999-10-01 |
| Date Added to Maude | 2011-12-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. CONNIE MCBROOM |
| Manufacturer Street | 1450 E. BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995985 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS |
| 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 | SAFHS 2000 MOU ASSEMBLY |
| Generic Name | BONE GROWTH STIMULATOR |
| Product Code | LPQ |
| Date Received | 2011-12-13 |
| Catalog Number | 71034014 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-13 |