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 2020-03-23 for DUODOPA_DUOPA 062941 manufactured by Abbvie - Medical Device Center.
[184484772]
Reference record (b)(4). Catalog number 062941-001 is the international list number which meets the requirements of the similar product listed which is the us list number. The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed. Pneumoperitoneum, stoma site infection, and gastric / bowel perforation are known complications 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
[184484773]
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. The spouse reported that the patient remained hospitalized due stoma site pain. The patient was found to have a pneumoperitoneum. The patient was also found to have a stoma infection which was treated with 500mg of cefuroxime every 12 hours. On (b)(6) 2020 the patient was discharged but still had pain. The patient had no symptoms of an infection but stoma irritation. The spouse reported that the event of stoma pain was due to post peg placement of pneumoperitoneum and the peg tube was removed on an unknown date. On (b)(6) 2020, the patient was admitted to the hospital with a gastric perforation and died. It was unknown if an autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00203 |
| MDR Report Key | 9866125 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2018-05-11 |
| 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 | 0 |
| 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 |
| Lot Number | 32195288 |
| 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. Other; 3. Required No Informationntervention | 2020-03-23 |