MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-02-14 for DORMIA NSTONE 4 HEL WIRE CH04 EXT2241002 EXT224 manufactured by Coloplast A/s.
[179510361]
After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number 4700827. Checking the quality databases revealed no anomaly in connection with the described defect. Unfortunately no sample is available from the customer and we cannot go further than the documentary investigation, which didn't reveal any anomaly recorded during production. The product reference ext2241002 lot 4700827 must be used for kidney stones and not for gallstones, as declared by the doctor. We believe this is a misuse of our ext224 medical device. According the instructions for use sh2138 : indications: extraction of urinary tract calculi. It is concluded that the risks identified are still acceptable and considered as safe. No similar case was found for catalog# ext224.
Patient Sequence No: 1, Text Type: N, H10
[179510362]
As reported to coloplast though not verified, the patient was admitted to the hospital on (b)(6) 2016 for vesicochol? Docienne lithiasis. During this intervention on (b)(6) 2016, under general anesthesia, the dormia was used in a digestive endoscope to extract gallstones. The surgeon practiced an attempt to extract the calculus by the main biliary duct, with dilation of the bile duct for the passage of a dormia. The first two passages did not bring back any stone, and during the third attempt, the dormia catheter got blocked. Pancreatitis is inevitable, and without any clinical, biological or radiographic translation, it was necessary to intervene in emergency, within twelve hours in order to extract this deleterious obstacle for the pancreatic function. On (b)(6) 2016, an intervention was performed. During this intervention, in the recovery room, the patient was victim of a massive inhalation, with an unfavorable evolution. Subsequently, she suffered a septic shock. A tracheostomy was performed on (b)(6) 2016 with complications from obstructions and skin fistulas. The trachea ct scan confirmed the two fistulas on (b)(6) 2016. The patient died on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610711-2020-00006 |
| MDR Report Key | 9713831 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-15 |
| Date of Event | 2016-06-29 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2015-07-07 |
| Date Added to Maude | 2020-02-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE PERRYMAN |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | COLOPLAST A/S MANUFACTURING FRANCE |
| Manufacturer Street | 9 AVENUE EDMOND ROSTAND |
| Manufacturer City | SARLAT-LA-CANEDA, 24206 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 24206 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORMIA NSTONE 4 HEL WIRE CH04 |
| Generic Name | URETERAL STONE DISLODGER |
| Product Code | FFL |
| Date Received | 2020-02-14 |
| Model Number | EXT2241002 |
| Catalog Number | EXT224 |
| Lot Number | 4700827 |
| Device Expiration Date | 2017-06-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2020-02-14 |