MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-25 for DUODOPA_DUOPA 062943 manufactured by Abbvie - Medical Device Center.
[186010452]
Reference record (b)(4). Catalog number is the international list number which is similar to us list number of 062918. A sample return is expected and a follow up medwatch report will be submitted upon completion of investigation. A bezoar is a known complication of a j-peg tube placement. (b)(4). If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186010453]
On (b)(6) 2018, a patient in (b)(6) underwent placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube. A nurse reported that during a gastroscopy, the patient? S intestinal tube was found to have a bezoar. The intestinal tube was replaced and the patient was not hospitalized.
Patient Sequence No: 1, Text Type: D, B5
[188575639]
(b)(4). The click adaptor and j-tube were received at abbvie for examination. The j-tube was received in two segments. The click adaptor was connected to one segment of the j tube. A visual inspection was performed. A bezoar was observed near the bolus end of the j-tube. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188575640]
Additional information received on 27 mar 2020: sample return evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00210 |
| MDR Report Key | 9879502 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-29 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2018-01-22 |
| 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 | 32041278 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 |