MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-05-01 for PLASTIBELL HOSP BULK 1.3 CM D 9213 manufactured by Hollister Incorporated.
[21427911]
Patient had been sent home; after a few days, they began to develop problems urinating. Patient was examined in the er, and it was noted by personnel that the plastibell had broken in half. The plastibell unit was removed; the patient was sutured and released without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219232-2009-00004 |
| MDR Report Key | 1373744 |
| Report Source | 99 |
| Date Received | 2009-05-01 |
| Date of Report | 2009-04-30 |
| Date of Event | 2009-02-01 |
| Date Facility Aware | 2009-02-18 |
| Report Date | 2009-04-30 |
| Date Reported to FDA | 2009-05-01 |
| Date Reported to Mfgr | 2009-05-01 |
| Date Added to Maude | 2010-03-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL HOSP BULK 1.3 CM |
| Generic Name | PLASTIBELL CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2009-05-01 |
| Model Number | D 9213 |
| Lot Number | 8I01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | LIBERTYVILLE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-01 |