MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-11 for PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM 88402 manufactured by Hollister Incorporated.
| Report Number | 9616668-2019-00004 |
| MDR Report Key | 8988855 |
| Report Source | CONSUMER |
| Date Received | 2019-09-11 |
| Date of Report | 2019-09-11 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2019-08-26 |
| Date Added to Maude | 2019-09-11 |
| 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 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8476802170 |
| Manufacturer G1 | HOLLISTER ULC |
| Manufacturer Street | FOXFORD RD. REHINS |
| Manufacturer City | BALLINA, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM |
| Generic Name | PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM |
| Product Code | EXB |
| Date Received | 2019-09-11 |
| Catalog Number | 88402 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE. 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-11 |