MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-30 for DUODOPA_DUOPA 062945 manufactured by Abbvie - Medical Device Center.
[185772568]
Reference record (b)(4). Catalog number is the international list number which is similar to us list number of 062912. The device involved in the event remained implanted in the patient; therefore, a return sample evaluation is unable to be performed. (b)(4). A buried bumper 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
[185772569]
On (b)(6) 2019 a patient in (b)(6) underwent a procedure for the re-placement of a percutaneous endoscopic gastrostomy (peg) tube. It was reported that since (b)(6) 2020 the patient had not been able to mobilize the peg tube. The patient was referred to a surgical consultation with observation of buried bumper syndrome. Duodopa therapy was not discontinued. The patient was hospitalized on (b)(6) 2020 for jejunal tube replacement due to a clogged tube. When performing the upper digestive endoscopy on (b)(6) 2020, the assumption of buried bumper syndrome was confirmed. The surgeon removed the jejunal tube and left the peg tube in position. Patient was discharged on (b)(6) 2020 with the recommendation to present himself over a month for the extraction of the peg tube. Patient started oral therapy for parkinson's disease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00222 |
| MDR Report Key | 9897401 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2017-11-23 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Catalog Number | 062945 |
| Lot Number | 32474357 |
| 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. Required No Informationntervention | 2020-03-30 |