MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2011-09-23 for STAN S31 FETAL HEART MONITOR SYS 101003 manufactured by Neoventa Medical Ab.
[2345624]
After delivery, the leg plate was disconnected by the research rn who did not note any lesion at the time. After the pt was transferred to the postpartum room her mother noticed a blister on the right thigh and informed clinical nurse. The blister was about 1cm in diameter with surrounding erythema at the location of the leg plate placement. The regular stan strap had been used and the pt was on stan from (b)(6) 2011 at 20:30 to (b)(6) 2011 at 09:10. The pt did report a tendency for easy bruising. The lesion was beginning to heal by the time she left the hosp. The blister was treated with antibiotic ointment.
Patient Sequence No: 1, Text Type: D, B5
[9358131]
The event took place at (b)(6), who are participating in a (b)(4) trial. The event was reported to neoventa as a study adverse event (not serious). The legplate cable has been exchanged. Neoventa concludes that the event is related to the concomitant product: (b)(4) leg plate ((b)(4)). The event will therefore be reported to the producer of this product: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2011-00002 |
| MDR Report Key | 2281239 |
| Report Source | 02 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-09-21 |
| Date of Event | 2011-09-08 |
| Date Mfgr Received | 2010-09-10 |
| Date Added to Maude | 2012-05-04 |
| 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 | MARIA GRANBERG, MEDICAL DIR |
| Manufacturer Street | NORRA AGATAN 32 |
| Manufacturer City | MOLNDAL SE-43135 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-43135 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAN S31 FETAL HEART MONITOR |
| Generic Name | HEO: OBSTETRIC DATA ANALYZER |
| Product Code | HEO |
| Date Received | 2011-09-23 |
| Model Number | SYS 101003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOVENTA MEDICAL AB |
| Manufacturer Address | MOEINDAL SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-23 |