MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for INVIEW MEC STANDARD 29MM MEDIUM 97529 manufactured by Hollister Incorporated.
| Report Number | 1480288-2020-00001 |
| MDR Report Key | 9835786 |
| Report Source | CONSUMER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| 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. LINDA WISOWATY |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE., IL |
| Manufacturer Country | US |
| Manufacturer Phone | 6802170 |
| Manufacturer G1 | C. R. BARD, INC |
| Manufacturer Street | AV GRAL ROBERTO FIERRO 6123 CIUDAD |
| Manufacturer City | JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVIEW MEC STANDARD 29MM MEDIUM |
| Generic Name | INVIEW MALE EXTERNAL CATHETER, SIZE MEDIUM |
| Product Code | EXJ |
| Date Received | 2020-03-16 |
| Catalog Number | 97529 |
| Lot Number | JUDR0138 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE., US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |