MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-24 for PLASTIBELL 1-2 CM manufactured by Hollister Inc..
[202931]
Have had several strings on the product that have broken while performing circumcision. The string breaks when being tightened before knotting it and removing foreskin. Have been told repeatedly by the co that they have never received a product complaint of this nature and have no other centers reporting this problem.
Patient Sequence No: 1, Text Type: D, B5
[223467]
Add'l info rec'd from mfr 3/14/01: hollister inc had requested and did not receive samples of device from the user facility; therefore, testing of the actual device could not be performed. During the investigation, the facility reported that the breakage of the ligature was occurring when used by one physician. The facility also reported that other physicians in the facility have used the device without incident. Hollister inc has reviewed its product complaint files and has determined that no adverse trends exist for this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002900 |
| MDR Report Key | 308271 |
| Date Received | 2000-11-24 |
| Date of Report | 2000-11-22 |
| Date of Event | 2000-11-21 |
| Date Added to Maude | 2000-12-14 |
| 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 | 0 |
| 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 | PLASTIBELL 1-2 CM |
| Generic Name | CIRCUMCISION BELL |
| Product Code | FHG |
| Date Received | 2000-11-24 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | 7F11AL |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 298254 |
| Manufacturer | HOLLISTER INC. |
| Manufacturer Address | 2000 HOLLISTER DR LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-11-24 |