MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for PLASTIBELL D 9233 manufactured by Hollister Incorporated.
[120253519]
Customer stated there were sharp edges on a plastibell that was on a patient where the handle snaps off. Approximately 4. 5 hrs after the circumcision, there were two incidents of active bleeding, after which time the plastibell was removed. No medical intervention was given other than removing the plastibell. Another plastibell was opened but not used, which also displayed sharp edges. The patient has since been discharged and is stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1422443-2018-00002 |
| MDR Report Key | 7870180 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-08-12 |
| Date Facility Aware | 2018-08-13 |
| Report Date | 2018-10-10 |
| Date Reported to FDA | 2018-10-10 |
| Date Reported to Mfgr | 2018-09-12 |
| Date Mfgr Received | 2018-08-13 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2018-09-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHERYL GOFF |
| Manufacturer Street | 1931 NORMAN DRIVE SOUTH |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475735944 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 1502 EAST LAHARPE |
| Manufacturer City | KIRKSVILLE MO 63501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLASTIBELL |
| Generic Name | PLASTIBELL CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-08-22 |
| Model Number | D 9233 |
| Catalog Number | D 9233 |
| Lot Number | 7F03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 1502 EAST LAHARPE KIRKSVILLE MO 63501 US 63501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |