MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2020-03-25 for DUODOPA_DUOPA 062943 manufactured by Abbvie - Medical Device Center.
[186007711]
Reference record (b)(4). Catalog number is the international list number which is similar to us list number of 062918. The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed. A bezoar is a known complication of a j-tube placement. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186007712]
On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube. In (b)(6) 2020 during a nurse visit, the patient? S intestinal tube was difficult to flush and could not be moved. On (b)(6) 2020 during a scheduled tubing replacement, the gastroscopy revealed that the intestinal tube had knots with a bezoar and found to be in the stomach. Unsuccessful attempts were made to remove the intestinal tube with peg tube and the patient experienced decreased oxygen saturation to 90-92%. The patient was not hospitalized and was discharged. At the time of report, the it was unknown if the tubing was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00207 |
| MDR Report Key | 9878776 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-11-27 |
| Date Added to Maude | 2020-03-25 |
| 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. TERRY INGRAM |
| Manufacturer Street | 1675 LAKESIDE DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8479385350 |
| Manufacturer G1 | ABBVIE - MEDICAL DEVICE CENTER |
| Manufacturer Street | 1675 LAKESIDE DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODOPA_DUOPA |
| Generic Name | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | KNT |
| Date Received | 2020-03-25 |
| Catalog Number | 062943 |
| Lot Number | 32482238 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBVIE - MEDICAL DEVICE CENTER |
| Manufacturer Address | 1675 LAKESIDE DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |