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 2020-03-25 for DUODOPA_DUOPA DUODOPA PEG TUBE manufactured by Abbvie - Medical Device Center.
[186715847]
Reference record (b)(4). The device involved in the event remained implanted in the patient and was not returned; 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
[186715848]
On (b)(6) 2020, a patient in the usa underwent placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube. On (b)(6) 2020, the patient? S spouse reported that the patient developed a stoma site infection a week to 10 days after having the peg/j-tube placed. On (b)(6) 020, the stoma was swabbed at an urgent care facility, which revealed streptococcus, and the patient was prescribed 500mg of oral cipro twice a day for 7 days. It was reported that the infection resolved within 7 days after starting the cipro.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010757606-2020-00209 |
| MDR Report Key | 9879220 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Catalog Number | DUODOPA PEG TUBE |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-25 |