MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-01 for PLASTIBELL UNK manufactured by Unk.
[16481101]
Plastibell used for circumcision had been pushed too far down on glans penis during procedure causing inability for plastibell to come off and resulting in tourniquet injury to distal glans penis. Device initially could not be removed; finally had to be cut off with a ring cutter. Infant still has ring type erosion into glans. Pictures of injury available. It appears to rptr that this kind of injury could easily happen again because of the opening in the end of the bell. This procedure was done in another institution and the child followed up at rptr's office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021752 |
| MDR Report Key | 330131 |
| Date Received | 2001-05-01 |
| Date of Report | 2001-05-01 |
| Date of Event | 2001-04-20 |
| Date Added to Maude | 2001-05-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL |
| Generic Name | CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2001-05-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 319495 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-05-01 |