MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2010-09-17 for STAN S31 FETAL HEART MONITOR SYS 101003 manufactured by Neoventa Medical Ab.
[2739969]
Pt noted to have inflammation (dermatitis) on right thigh in shape of fse cable. Area noted to be blistered. Pt on stan monitor from 15. 55 (b)(6) 2010 until 11. 00 (b)(6) 2010. Nursing staff on post partum unit applying a and d ointment and keeping area clean and dry. The superficial presentation is analogous to a 2nd degree burn with desquamation (= shedding of the outermost layer of the skin).
Patient Sequence No: 1, Text Type: D, B5
[9932312]
The event took place at (b)(6), who are participating in a (b)(6) randomized controlled trial. The event was reported to neoventa as a study adverse event. A neoventa rep visited the hospital the day after the event was reported, but was prevented to investigate the product by the risk management of the hospital. Doctor (b)(6), has been providing the following update on (b)(6) 2010: "the official (risk management) report did not find a problem with stan. They are still looking into options for outside review. I found out today that risk management reported the event to the fda yesterday. The fda acknowledgment indicates they will make contact if they determine that additional info is needed. " 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)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00012 |
| MDR Report Key | 2594171 |
| Report Source | 02 |
| Date Received | 2010-09-17 |
| Date Mfgr Received | 2010-09-10 |
| Date Added to Maude | 2012-06-05 |
| 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 | 2010-09-17 |
| 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 | MOLNDAL SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-17 |