MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-30 for NEIVERT TONSIL SNARE * 70651 OR 70660 manufactured by Weck (pilling Weck Corp).
[59664]
On 11/15/94, a 4 year old was admitted for a tonsillectomy. During the surgical procedure, blunt dissection partially freed the tonsil. While removing it with a snare wire, the tip of the snare unit broke. This small metallic end of the snare was not located visually by direct laryngoscopy or by x-ray of the chest which includes the upper half of the abdomen. Hypothesis is that the missing tip of the snare may have been suctioned out during the procedure, or if retained, will pass through the gastrointestinal tract. Mfr's rep was notified. 1/5/95 delay in notification was due to hosp's difficulty in identifying the instrument's mfr. 1/10/95, mfr's rep identified product and the tonsil snare was given to him at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 88135 |
| MDR Report Key | 88135 |
| Date Received | 1995-01-30 |
| Date Added to Maude | 1997-05-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEIVERT TONSIL SNARE |
| Generic Name | NEIVERT TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 1995-01-30 |
| Model Number | * |
| Catalog Number | 70651 OR 70660 |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 87251 |
| Manufacturer | WECK (PILLING WECK CORP) |
| Manufacturer Address | P.O. BOX 12600 ONE WECK DR DURHAM NC 27709 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-30 |