MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-09-18 for PLASTIBELL * manufactured by Hollister, Inc..
[22001]
A 2 yr. Old male had circumcision, due to balanitis with contracture of foreskin, using a bell manufactured by co. Pt seen in er 5 days later with pain, penile swelling, dysuria, hematuria treated with antibiotic and pain med. Seen again in er on 9/4/95, ring fell off on 9/3/95, has increased swelling of penis foreskin, pain on urination, brown crusting and bright red erythema. Told to continue antibiotic, use ice bags. Pt continued to have pain, seen in followup by several pediatric and urologic specialists. Mother states pt has significant excess skin hanging down as a result of the acute swelling, states physician has said the child may be sterile, must wait until child reaches puberty to determine; may also need plastic/cosmetic surgery. Pt is now very frightened of doctors/hospitals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1480288-1996-00001 |
| MDR Report Key | 38733 |
| Report Source | 06 |
| Date Received | 1996-09-18 |
| Date of Report | 1996-07-23 |
| Date of Event | 1995-08-28 |
| Date Facility Aware | 1995-09-04 |
| Date Mfgr Received | 1996-08-21 |
| Date Added to Maude | 1996-09-20 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL |
| Generic Name | FOR CIRCUMCISIONS |
| Product Code | FHG |
| Date Received | 1996-09-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 39970 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 2000 HOLLISTER DR. LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 1996-09-18 |