MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-07 for BACKSTOP (BACKSTOP) 390-900 manufactured by Pluromed Inc..
[5693255]
This unsolicited device case came from (b)(6) was received on (b)(6) 2015 from a healthcare professional. This case involves a patient (unknown demographics) who received treatment with backstop and the surgeon thought that he did some damage to the ureteral wall. No relevant medical history, past drugs, concurrent conditions and concomitant medications were reported. On (b)(6) 2015, patient's surgeon used backstop (clear gelx 3f catheter kit) (anatomical location, indication, batch/lot number and expiration date: not provided) and wanted to insert the tip of the 3fr catheter past a stone in the patient's ureter. Reportedly, the stone was impacting the patient's ureter quite a bit. While the surgeon was trying to insert the tip of the 3fr catheter past the stone, he felt resistance pushing it. The surgeon thought he did some damage to the ureteral wall. It was reported that the surgeon managed to get a wire past the stone and then a stent. He thought he would stent it, leave it to settle and come back another day. It was reported that the problem was noticed in the patient during the procedure. Action taken: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008867907-2015-43373 |
| MDR Report Key | 4671491 |
| Report Source | 01,05 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-03-23 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-04-10 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN SHARMA, MD |
| Manufacturer Street | 55 CORPORATE DRIVE MAIL STOP: 55C-235A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089812784 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACKSTOP (BACKSTOP) |
| Product Code | ONJ |
| Date Received | 2015-04-07 |
| Model Number | 390-900 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLUROMED INC. |
| Manufacturer Address | WOBURN MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-07 |