MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-05 for PLASTIBELL HOSP BULK 1.2 CM D 9212 manufactured by Hollister Inc..
[4393194]
The unit broke in half during a circumcision procedure. The physician was tying the string and the plastibell popped off and hit the physician in the chest. When the physician picked the plastibell off the floor, he noticed that the string had tightened around the patient's penis, cutting off the tip. The physician cut off the string from the patient's penis. The patient had to have an add'l surgery. The hospital has been using the product since november 2007. The physician has been using the product for 10 years. A review of the device history for this particular model and lot number was performed, and no abnormalities were discovered. A review of complaint history for this product reveals no similar incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1422443-2014-00001 |
| MDR Report Key | 3832122 |
| Report Source | 05 |
| Date Received | 2014-05-05 |
| Date of Report | 2014-05-02 |
| Date of Event | 2014-04-03 |
| Date Mfgr Received | 2014-04-04 |
| Device Manufacturer Date | 2013-04-06 |
| Date Added to Maude | 2014-05-28 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JERI HILL |
| Manufacturer Street | 1931 NORMAN DR. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475735947 |
| Manufacturer G1 | HOLLISTER INC. |
| Manufacturer Street | 1502 EAST LAHARPE |
| Manufacturer City | KIRKSVILLE MO 63501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL HOSP BULK 1.2 CM |
| Generic Name | PLASTIBELL CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2014-05-05 |
| Model Number | D 9212 |
| Catalog Number | D 9212 |
| Lot Number | 3D06 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INC. |
| Manufacturer Address | 1502 EAST LAHARPE KIRKSVILLE MO 63501 US 63501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-05-05 |