MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-11 for HOLLISTER 9233 manufactured by Briggs.
[1400694]
Baby had a plastibell 1. 3 circumcision performed on (b) (6) 2010 by dr (b) (6) ob/gyn. Mother called on (b) (6) 2010 stating that the ring had slipped down below the glans. Baby seen at the hosp ob dept where dr (b) (6) removed the ring with vaseline and traction. (dr (b) (6) had used these products for years without any issues - we contacted mfr to ask if they had made any product changes - they said no).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016360 |
| MDR Report Key | 1726769 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-06-07 |
| 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 | 9233 |
| Catalog Number | 9233 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS |
| Manufacturer Address | 1931 NORMAN DRIVE S. WAUKEGAN IL 60085671 US 60085 6715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-11 |