MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-01-29 for PERIFIX? 332230 manufactured by B. Braun Medical Inc..
[177972784]
This report has been identified as b. Braun medical internal report number (b)(4). Although the device involved is not available for evaluation, the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[177972785]
As reported by medwatch number mw5091909: "patient underwent cervical steroid injection. The injection was administered on first pass without any documented complications on (b) (6)2019. The patient reported left arm weakness. Ct ordered and pt. Outpatient ct of cervical spine w/contrast, myelogram-central-cord expanded from c4-c7. Likely an intramedullary hematoma. There is a 3mm needle fragment dorsal to the cord at c6-c7. Patient admitted for observation. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00007 |
| MDR Report Key | 9645289 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-01-29 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2019-08-28 |
| Date Added to Maude | 2020-01-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIFIX? |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-01-29 |
| Model Number | 332230 |
| Catalog Number | 332230 |
| Lot Number | 0061694547 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |