MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-19 for PLASTIBELL HOSP. BULK 1.1CM D 9211 manufactured by Briggs Healthcare.
[19499473]
While doing a routine plastibell circ by doctor she placed an intact plastibell ring on the penis and tied the string per protocol and took foreskin off. Once tope of plastibell was taken off it was noticed by nurse and doctor that the plastibell was cracked in two spots and folding in on the penis. The bleeding was minimal at this point and doctor called urology doctor right after plastibell was noticed to be (b)(6) for further eval. From procedure note: at the time of placement of the plastibell, the 1. 1 plastibell used in this procedure was completely intact. The plastibell was placed over the glans and the foreskin was pulled back over the glans and plastibell, in correct position to tie the string. The string was then tied. As the string was tied, the plastibell remained a completely intact circle, the skin blanched as expected. The remaining foreskin was removed with sterile scissors and then the tab was removed from the plastibell. There did not seem to be anything out of the ordinary when removing the tab, normal amount of pressure required to remove. After removing the tab, it was noted that the plastibell had cracked at two points and was no longer in the shape of circle surrounding the glans. The two edge of the cracked plastibell shifted so that broken edges of the ring were overlapping each other. Due to concern of the cracked plastibell, inability to achieve complete hemostasis due to the cracked plastibell not allowing the string to be tight, and concern that the plastibell could shift and cause pressure on the glans, urology was consulted.
Patient Sequence No: 1, Text Type: D, B5
[31581610]
Additional information received from reporter 06/29/2015: initial report stated that an intact plastibell ring was placed on the patient's penis and ties per protocol. The foreskin was removed. Upon removal of the handle, the nurse and doctor noticed that the plastibell was cracked in two spots and folding in on the penis. The plastibell was no longer in the shape of a circle. The two edges of the cracked unit shifted so that the broken edges were overlapping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040334 |
| MDR Report Key | 4450382 |
| Date Received | 2015-01-19 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-18 |
| Date Added to Maude | 2015-01-27 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL HOSP. BULK 1.1CM |
| Generic Name | PLASTIBELL |
| Product Code | FHG |
| Date Received | 2015-01-19 |
| Model Number | D 9211 |
| Catalog Number | D 9211 |
| Lot Number | 4J06 |
| ID Number | NA |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS HEALTHCARE |
| Manufacturer Address | 1931 NORMAN DR. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-19 |