MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-23 for MABIS HEALTHCARE manufactured by Mabis Healthcare/care Precise.
[2114271]
While physician was performing a circumcision on an infant, upon trying to tie string around plastibel, string broke, requiring to open additional product. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021125 |
| MDR Report Key | 2142481 |
| Date Received | 2011-06-23 |
| Date of Report | 2011-06-21 |
| Date of Event | 2011-06-16 |
| Date Added to Maude | 2011-07-01 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MABIS HEALTHCARE |
| Generic Name | PLASTIBEL |
| Product Code | FHG |
| Date Received | 2011-06-23 |
| Lot Number | OK 14 |
| Device Expiration Date | 2015-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MABIS HEALTHCARE/CARE PRECISE |
| Manufacturer Address | 4757 SOUTH HUDSON PLACE TULSA OK 74135 US 74135 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-23 |