MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for PLASTIBELL CIRCUMCISION DEVICE manufactured by Briggs Medical Service Company.
[93752162]
During the circumcision when using a plastibell device the tab on the plastibell is snapped off and usually leaves a smooth finish. However, in this case, it didn't snap evenly and caused sharp edges to remain behind. This did not cause patient injury/harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073715 |
| MDR Report Key | 7079045 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-11-11 |
| Date Added to Maude | 2017-12-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLASTIBELL CIRCUMCISION DEVICE |
| Generic Name | BELL, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2017-12-01 |
| Lot Number | 5D06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS MEDICAL SERVICE COMPANY |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |