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 2020-03-31 for DUODOPA_DUOPA 062943 manufactured by Abbvie - Medical Device Center.
[186718698]
Reference record (b)(4). Catalog number is the international list number which is similar to us list number of 062918-001. The device involved in the event was not returned and was discarded; therefore, a return sample evaluation is unable to be performed. Peritonitis is a known complication of a peg tube/ j-tube placement. Per instructions for use (ifu), the peg tube should be pulled until elastic resistance is felt, kept under tension, fixation plate should be secured into position using the clip, and remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall to the inner abdominal wall. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186718699]
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 the procedure, the patient experienced abdominal pain and elevated wbc (14. 39). The patient was prophylactically treated with intravenous augmentin 1200mg three times a day. On (b)(6) 2020 the patient was diagnosed with acute peritonitis and elevated crp (44. 9). The peg/peg-j tubes were removed and duopa therapy was suspended and initiated oral therapy. Repeat blood test completed on (b)(6) 2020 showed increased crp (281. 4) level. On (b)(6) 2020 the patient experienced repetitive vomiting and swelling in the abdomen. X-ray confirmed gastroparesis and blood test result showed continued wbc (14. 11) elevation. On an unknown date the patient began two intravenous antibiotic therapy; cefepime 2000mg three times a day from (b)(6) 2020 to (b)(6) 2020 and amantadine sulfate 200mg two times a day. On (b)(6) 2020, repeat blood test resulted in wbc (5. 53) within normal limits and decreased crp (7. 2). The patient was discharged from the hospital on (b)(6) 2020 and referred to a rehabilitation center. Duopa therapy has been discontinued and the patient continues to take oral medications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00223 |
| MDR Report Key | 9902817 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-19 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-05-17 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Catalog Number | 062943 |
| Lot Number | 32204248 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-31 |