MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-05 for ENT FORCEPS ALLIGATOR manufactured by Storz.
[15174702]
The patient, a (b)(6) child, presented with hoarseness and persistent otitis media on multiple outpatient visits. An elective ambulatory procedure was scheduled and the patient underwent bilateral tube placement and laryngoscopy on (b)(6) 2013 without complications. Of note, prior to the procedure, the tip of the alligator forceps appeared to have broken apart from the bottom; the bottom part was found on the floor and both pieces were retrieved. There was no harm to the patient, and he was discharged home following the procedure on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034232 |
| MDR Report Key | 3619226 |
| Date Received | 2014-02-05 |
| Date of Report | 2014-02-04 |
| Date of Event | 2013-12-18 |
| Date Added to Maude | 2014-02-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ENT FORCEPS ALLIGATOR |
| Generic Name | ENT FORCEPS |
| Product Code | KAE |
| Date Received | 2014-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-05 |