MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-10 for GLASSMAN VISCERA RETAINER 3204 manufactured by Adept-med International, Inc..
[64286075]
Reporting physician states : he has utilized a glassman viscera retainer, fish at least 500 times in the past without incident. Not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[64286076]
Received a telephone call from reporting party on 12/08/2016 who relayed the following information : on (b)(6) 2016, j. Doe had a surgical procedure that required a large abdominal incision. A glassman viscera retainer, size medium, item# 3204 was used in the closure. J. Doe did well after surgery. On (b)(6) 2016, j. Doe was taken for an x-ray, unrelated to the original surgery and a glassman viscera retainer radiopaque strip was visible in the x-ray and identified as a retained foreign object. J. Doe was taken to surgery on that same day, 2 skin sutures and 1 facial suture from the original surgery were removed and the glassman viscera retainer was removed without incident. Reporting party states the 2nd surgery was completed in 15 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918699-2017-70001 |
| MDR Report Key | 6236863 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-05 |
| Date of Event | 2016-11-16 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE QUIGLEY |
| Manufacturer Street | 665 PLEASANT VALLEY RD. |
| Manufacturer City | DIAMOND SPRINGS CA 95619 |
| Manufacturer Country | US |
| Manufacturer Postal | 95619 |
| Manufacturer Phone | 5306211220 |
| Manufacturer G1 | ADEPT-MED INTERNATIONAL, INC |
| Manufacturer Street | 665 PLEASANT VALLEY RD |
| Manufacturer City | DIAMOND SPRINGS CA 95619 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95619 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLASSMAN VISCERA RETAINER |
| Generic Name | VISCERA RETAINER, FISH ? |
| Product Code | GCZ |
| Date Received | 2017-01-10 |
| Model Number | 3204 |
| Catalog Number | 3204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADEPT-MED INTERNATIONAL, INC. |
| Manufacturer Address | 665 PLEASANT VALLEY RD DIAMOND SPRINGS CA 95619 US 95619 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-10 |