MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2008-04-02 for EXOGEN COUPLING GEL 71034124 manufactured by Smith & Nephew, Inc., Orthopaedic Div.
[19154453]
It was reported that the pt had a localized reaction to the coupling gel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2008-00108 |
| MDR Report Key | 1023361 |
| Report Source | 00,05 |
| Date Received | 2008-04-02 |
| Date of Report | 2008-03-25 |
| Date of Event | 2008-03-25 |
| Date Mfgr Received | 2008-03-25 |
| Date Added to Maude | 2008-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR PHILLIP EMMERT, SPEC II |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXOGEN COUPLING GEL |
| Generic Name | ULTRASOUND COUPLING GEL |
| Product Code | MUI |
| Date Received | 2008-04-02 |
| Model Number | NA |
| Catalog Number | 71034124 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 990491 |
| Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-04-02 |