MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for Brachytherapy RPG-18 manufactured by Riverpoint Medical.
[137284516]
Riverpoint medical received a complaint regarding holes in packaging for the rpg-18 brachytherapy grid product. Riverpoint performed a visual inspection of packaging on the products and an additional dye penetration test was conducted and confirmed breach of sterile barrier. There have been no reported adverse events associated with the packaging failure or reports of use of breached packaging product. A product removal was initiated by riverpoint on 08/february/2019 (initial removal report 3006981798-02072019-002-r) for the rpg-18 grid product.
Patient Sequence No: 1, Text Type: N, H10
[137284517]
Riverpoint medical received a customer complaint on (b)(6) 2019 indicating a possible issue with the integrity of packaging for the rpg-18 grid product. According to the reporter, grid product was returned due to breached packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006981798-2019-00001 |
| MDR Report Key | 8323805 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-01-10 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2019-02-08 |
| 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 | MR. EDWIN ANDERSON |
| Manufacturer Street | 825 NE 25TH AVE. |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal | 97232 |
| Manufacturer Phone | 5035178001 |
| Manufacturer G1 | RIVERPOINT MEDICAL |
| Manufacturer Street | 825 NE 25TH AVE. |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97232 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | Brachytherapy |
| Generic Name | BRACHYTHERAPY GRID |
| Product Code | IWJ |
| Date Received | 2019-02-08 |
| Model Number | RPG-18 |
| Lot Number | 18101521 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIVERPOINT MEDICAL |
| Manufacturer Address | 825 NE 25TH AVE. PORTLAND OR 97232 US 97232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |