MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-16 for PLASTIBELL DEVICE * manufactured by *.
[17765230]
During the procedure in the nicu at the medical center, the lateral seals of a plastibell ring disrupted upon application of the cotton ligature. In effect, this caused a "bi-valve mollusk" type compression injury resulting in a 160 degree circumferential, deep laceration of the glans penis of the patient. Using direct pressure to control oozing, the patient lost ~ 3. 2 ml of blood from the laceration; and, was subsequently transported to a children's hospital for consultation and evaluation by pediatric urology and plastic surgery. Rptr is generating a report on this procedural complication; and, has secured the device in a lock-box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1039737 |
| MDR Report Key | 746538 |
| Date Received | 2006-01-17 |
| Date Added to Maude | 2006-08-14 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL DEVICE |
| Generic Name | * |
| Product Code | FHG |
| Date Received | 2006-07-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734336 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-17 |