MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-19 for POSTURE S-PORT NONE manufactured by The Sounders Group, Inc..
[82479]
Pt developed a left sided inguinal hernia after using the device for several weeks, and after one day of driving a lot. Due to recurrent stomach cramps, the pt had previously only been using the device intermittently for 2-3 hours at a time. The day of the event the pt noted significant scrotal swelling after use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014774 |
| MDR Report Key | 192398 |
| Date Received | 1998-10-19 |
| Date of Report | 1998-10-19 |
| Date of Event | 1998-08-01 |
| Date Added to Maude | 1998-10-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSTURE S-PORT |
| Generic Name | POSTURE SUPPORT DEVICE |
| Product Code | ISR |
| Date Received | 1998-10-19 |
| Model Number | POSTURE S-PORT |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | NONE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 186964 |
| Manufacturer | THE SOUNDERS GROUP, INC. |
| Manufacturer Address | 4250 NOREX DR. CHASKA MN 553183047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-19 |