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 2020-03-27 for DUODOPA_DUOPA 062945 manufactured by Abbvie - Medical Device Center.
[186716933]
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 was not returned; therefore a return sample evaluation was not performed. Gastrointestinal perforation is a labeled known event. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186716934]
On (b)(6) 2019, patient in (b)(6) underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube. On (b)(6) 2020, it was reported that, nurse visited the patient for abdominal pain and stoma care was performed. The patient had been visited by a gastroenterologist two months ago and suggested to have tubing replacement. It was recommended for pain to visit an on-call hospital. Additional information received on (b)(6) 2020. It was reported that the patient had stoma site inflammation externally and internally with malodorous discharge. On (b)(6) 2020 the patient underwent gastroscopy, stoma culture and ct of the abdomen. Report indicated that a fistula was found in left transverse colon and from the culture obtained, it was found that there is stool outflow from the stomach. The peg-j tube was removed. According to the surgeon, the bowel was eroded by a hard object and does not know if it was due to the tubings. Additional information indicated that on (b)(6) 2020 surgery was performed on the patient, and a part of the patient's stomach and intestine were removed. The surgery went well. Patient was treated with iv antibiotics flagyl and cefoxitin three times a day. The patient was discharged on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00219 |
| MDR Report Key | 9891865 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2016-09-23 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Catalog Number | 062945 |
| Lot Number | 32384386 |
| Device Expiration Date | 2020-02-29 |
| 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. Required No Informationntervention | 2020-03-27 |