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 062941 manufactured by Abbvie - Medical Device Center.
[186011477]
Reference number (b)(4). Catalog number is the international list number which is similar to us list number of 062910. The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed. Stoma site infection is a known complication of a peg- 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
[186011478]
On (b)(6) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube. After an unspecified amount of time, the patient experienced fluid outflow and pain at stoma area, diagnosed as a stoma site infection. Ceclor 500mg was recommended for 7 days, the patient was not hospitalized. The patient received antibiotics until (b)(6) 2020. On (b)(6) 2020, the stoma was hard on the upper side, which was an improvement, and it exuded pus at pressure. The gastroenterologist was informed and instructed the patient to continue the antibiotic for 1 week until (b)(6) 2020. The stoma area was treated with betadine solution every morning and evening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00211 |
| MDR Report Key | 9880980 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-07-31 |
| 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 | 062941 |
| Lot Number | 32312218 |
| 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 | 2020-03-25 |