MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-19 for QUANTUM TTC ESOPHAGEAL BALLOON DILATOR QD-18X8 manufactured by Cook Endoscopy.
| Report Number | 1037905-2020-00087 |
| MDR Report Key | 9729717 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-12 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-04-09 |
| Date Added to Maude | 2020-02-19 |
| 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 | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTUM TTC ESOPHAGEAL BALLOON DILATOR |
| Generic Name | KNQ, DILATOR, ESOPHAGEAL |
| Product Code | KNQ |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | QD-18X8 |
| Lot Number | W4200657 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |