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 2020-03-20 for DUODOPA_DUOPA 062945 manufactured by Abbvie - Medical Device Center.
[186700553]
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 and remained implanted in the patient; therefore, a return sample evaluation is unable to be performed. ? A pneumoperitoneum is a known complication of a peg tube placement. Per the instructions for use (ifu): to secure the peg tube, the peg tube should be pulled until elastic resistance is felt, keep under tension, secure fixation plate 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. (b)(4). If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186700554]
On (b)(6) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube. The patient was hospitalized for duopa therapy titration. On (b)(6) 2020 the patient experienced abdominal pain. Ct scan was completed on the same day and confirmed the presence of accumulated air in the abdomen. On (b)(6) 2020 the adverse event of abdominal pain resolved. Accumulation of air in the abdomen is ongoing and will continue to be monitored in the hospital. On (b)(6) 2020, it was reported that the adverse event of pneumoperitoneum has resolved and duopa therapy continues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00200 |
| MDR Report Key | 9861500 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-06-02 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Catalog Number | 062945 |
| Lot Number | 32384386 |
| Device Expiration Date | 2020-02-29 |
| 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 | 2020-03-20 |