MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-08 for UNKNOWN PRODUCT-MED manufactured by .
[135682095]
The complaint information has been forwarded to the supplier for investigation. Investigation results are pending at this time. A follow up report will be submitted once the investigation has been completed by the supplier.
Patient Sequence No: 1, Text Type: N, H10
[135682096]
Customer had an out patient procedure and was sent home with 2 reservoir drains, product code unknown. Customer provided picture of 'like' product from the internet as the only product identification. Customer reports that both drains stopped working 2-3 days after placement and discharge from facility. Customer returned to doctor's office for manual drainage and subsequently doctor replaced drains with another product. No further consequences reported by customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00264 |
| MDR Report Key | 8320968 |
| Report Source | CONSUMER |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-19 |
| Date of Event | 1980-01-10 |
| Date Mfgr Received | 2019-01-18 |
| Date Added to Maude | 2019-02-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DR. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PRODUCT-MED |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2019-02-08 |
| Model Number | UNKNOWN PRODUCT-MED |
| Catalog Number | UNKNOWN PRODUCT-MED |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-08 |