MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-23 for DUODOPA_DUOPA 062941 manufactured by Abbvie - Medical Device Center.
[186707439]
Reference record (b)(4). The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed. An ulcer is a known complication of a peg 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
[186707440]
On an unknown date, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube. Duopa treatment began (b)(6) 2018. On (b)(6) 2020 it was reported the patient had a gastric bleed high in the large intestine and also diagnosed with a gastric ulcer near the internal fixation plate of the peg tube on (b)(6) 2020. The gastric bleed was stapled/sutured on (b)(6) 2020 and patient was discharged from the hospital on (b)(6) 2020. The patient was treated with intravenous normal saline, one pint of intravenous platelets, five pints of blood transfusions and proton-pump inhibitor pantoprazole. The wife reported the patient had the peg and j tube replaced at the time of the repair of the gastric bleed because the patient was due for a routine replacement within the next month and added the gastric bleed was not related to the tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00202 |
| MDR Report Key | 9865441 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Catalog Number | 062941 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-23 |