MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-20 for DUODOPA_DUOPA 062910 manufactured by Abbvie - Medical Device Center.
[186700078]
Reference record (b)(4). Catalog number is the standard us list number. 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. Stoma site infection is a known complication 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
[186700079]
In (b)(6) 2018, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube. On (b)(6) 2020, the patient reported a stoma site infection and bruising around the tubing. On an unknown date, the patient was treated with oral antibiotic, keflex. On (b)(6) 2020, the patient reported that the infection has cleared up and will have tube replacement on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00199 |
| MDR Report Key | 9861496 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-26 |
| 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 | 062910 |
| 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. Required No Informationntervention | 2020-03-20 |