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 062941 manufactured by Abbvie - Medical Device Center.
[186717681]
Reference record (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 implanted in the patient and was not returned for evaluation; therefore a return sample evaluation was not performed. Peritonitis is a known complication of a peg tube placement. The instructions for use indicate, to secure the peg tube, pull on the abbvie peg tube until elastic resistance is felt and keep under tension and abbvie peg tube should 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
[186717682]
On (b)(6) 2020, patient in (b)(6) underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube. During the night after the procedure, the patient experienced severe abdominal pain and probably air in the stomach. The patient was treated with oxynorm (short-acting opioids for severe pain) 5 mg x 3 and paracetamol, and had normal bowel sounds. The following day, the patient experienced strong pain and was not able to breath properly. Patient was treated with pain medication morphine 2. 5mg and an abdominal x ray was done. Reportedly, the physician found that the distance between the inner and outer retention plate was too long, it was 2-3 cm. The patient was treated with prophylactic antibiotics tazocin 4 mg x 2 iv. On (b)(6) 2020, patient was transferred to short term rehabilitation and still experienced pain. On (b)(6) 2020, additional information received indicated that the patient experienced peritonitis. Patient also had a follow up check up and is doing well and duopa therapy is continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00220 |
| MDR Report Key | 9891799 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-11 |
| 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 | 062941 |
| 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 | 2020-03-27 |