MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-09 for HOLLISTER PLASTIBELL 9212 * manufactured by Hollister, Inc..
[260072]
During routine circumcision the device caused irritation and bleeding possibly the result of excessive rough edges remaining after preparing the device for use by removing the "handle".
Patient Sequence No: 1, Text Type: D, B5
[15605754]
Add'l info rec'd from mfr 4/17/03: review of the device history record for problems: device history record was reviewed for accuracy. The material lot used to produce the plastibell circumcision device part no. 9212, lot 2a01a was identified. Incoming inspection reports indicated no non-conformances. In addition, documentation exists to show that "crush test" on the plastibell was performed and met specifications for all in-house lots of material that made up lot 2a01a. Sterile lot history record was reviewed for accuracy and completeness and no non-conformities were found. Device evaluation: the actual failed unit was visually inspected using a magnification instrument. At the time of physical examination, the only burr found on the device was a burr associated with the area where the handle is removed from the bell body. The burr where the handle is detached from the bell body is inherent in the use of the device and is expected. However, the shape of the burr seen on the returned device is not typical of normal handle removal, it was noted during the visual examination that the burr did not extend either towards the inside or outside diameter of the bell body but was positioned directly over the bell body plastic rim. Conclusion: the root cause of the reported injury is unknown. A burr or plastic remnant is expected when the bell handle is removed. No manufacturing defects were found by examining the device or reviewing the device history records for this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026127 |
| MDR Report Key | 416252 |
| Date Received | 2002-09-09 |
| Date of Report | 2002-09-09 |
| Date of Event | 2002-09-02 |
| Date Added to Maude | 2002-09-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HOLLISTER PLASTIBELL |
| Generic Name | CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2002-09-09 |
| Model Number | 9212 |
| Catalog Number | * |
| Lot Number | 2A01A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 405284 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 2000 HOLLISTER DR. LIBERTYVILLE IL 60048 US |
| Baseline Brand Name | HOLLISTER PLASTIBELL |
| Baseline Generic Name | CIRCUMSION DEVICE |
| Baseline Model No | 9212 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-09-09 |