MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-26 for POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L 1859600 manufactured by Bard Access Systems.
[186527447]
As the lot number for the device was provided, a review of the device history records is currently being performed. Photos were provided for review. The device was not returned to the manufacturer for evaluation. The investigation is currently under way. Medical device - expiration date: 05/2021.
Patient Sequence No: 1, Text Type: N, H10
[186527448]
It was reported that approximately two days post port implant, the patient allegedly experienced redness, irritation, hives and itches around the port insertion site. Therefore, the patient received prescribed medication. Reportedly, the healthcare provider used hypoallergenic dressing for cleaning during port access. The patient was reported as stable..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01087 |
| MDR Report Key | 9887067 |
| Report Source | OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-03-01 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L |
| Generic Name | IMPLANTABLE PORT |
| Product Code | LJT |
| Date Received | 2020-03-26 |
| Model Number | 1859600 |
| Catalog Number | 1859600 |
| Lot Number | REDY1483 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |