MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-30 for HOLLISTER 9212 manufactured by Hollister, Inc.
[5495959]
Circumcision performed with plastibell on (b)(6) 2015. Baby unable to void following procedure. Required suprapubic tap and transfer to a pediatric hospital for care under pediatric urologist. Baby required surgically placed bladder drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040608 |
| MDR Report Key | 4491683 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-27 |
| Date of Event | 2015-01-17 |
| Date Added to Maude | 2015-02-09 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER |
| Generic Name | PLASTIBELL CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2015-01-30 |
| Catalog Number | 9212 |
| ID Number | ITEM #737 SM 1.2 CM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-01-30 |