MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for PLASTIBELL CIRCUMCISION DEVICE D 9233 manufactured by Hollister Incorporated.
| Report Number | 1422443-2019-00006 |
| MDR Report Key | 9151091 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-08-28 |
| Date Mfgr Received | 2019-08-28 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-10-03 |
| 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. CHERYL GOFF |
| Manufacturer Street | 1931 NORMAN DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475735944 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 1502 EAST LAHARPE |
| Manufacturer City | KIRKSVILLE MO 63501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLASTIBELL CIRCUMCISION DEVICE |
| Generic Name | PLASTIBELL CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2019-10-03 |
| Model Number | D 9233 |
| Catalog Number | D 9233 |
| Lot Number | 8G03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 1502 EAST LAHARPE KIRKSVILLE MO 63501 US 63501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-03 |