MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for ETHICON, 2-0 CHROMIC CUT TAPER SH G-123 #221 STUART DRUG & SURG. SUPPL manufactured by Ethicon.
[14986]
During surgical procedure, while suturing after right varicocelectomy performed, one portion of a small piece of chromic needle broke and was left within the rectus muscle or the subcutaneous tissue. Attempts made to identify the needle were unsuccessful. X-rays were taken and confirmed needle to be present within adbominal wall. Plan regarding needle was to determine if it is causing any problems. M. D. Believed needle could be localized fluoroscopically via radiologist and could subsequently cut down on the needle localization to remove this if necessary. At time of surgery it was felt best to leave it in and only remove it if it causes symptoms later. No symptoms later. Patient was discharged home follow-up care will be per surgeon. On 6/3/94, patient returned for out-patient surgery to remove retained portion of needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21130 |
| MDR Report Key | 21130 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-05-31 |
| Date of Event | 1994-05-20 |
| Date Facility Aware | 1994-05-20 |
| Report Date | 1994-06-02 |
| Date Reported to Mfgr | 1994-06-03 |
| Date Added to Maude | 1995-04-13 |
| 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 | ETHICON, 2-0 CHROMIC CUT TAPER SH |
| Generic Name | TAPER SH NEEDLE/SUTURE |
| Product Code | HAS |
| Date Received | 1994-07-29 |
| Model Number | G-123 |
| Catalog Number | #221 STUART DRUG & SURG. SUPPL |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21104 |
| Manufacturer | ETHICON |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1994-07-29 |