MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-11 for HOLLISTER 9234 manufactured by Briggs.
[1400695]
Baby had a plastibell 1. 4 circumcision performed on (b) (6) 2010 by dr (b) (6) ob/gyn. Dr (b) (6), attending family physician saw pt in the office as f/u routine visit and found the ring was below the glans. The glans had a blueish hue. Baby was sent to a hosp to see a urologist for ring removal - a ring cutter was used to remove device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016362 |
| MDR Report Key | 1726772 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-01-24 |
| Date Added to Maude | 2010-06-21 |
| 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 |
| 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 | 2010-06-11 |
| Model Number | 9234 |
| Catalog Number | 9234 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS |
| Manufacturer Address | 1931 NORMAN DR S. WAUKEGAN IL 60085671 US 60085 6715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-11 |