MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-06-10 for GLASSMAN VISCERA RETAINER 3204 manufactured by Adept-med Intl., Inc..
[40643698]
On (b)(6) 2015, adept-med was contacted by (b)(6). (b)(6) is representing (b)(6) in a law suit naming a hospital and hospital staff for failing to remove a glassman viscera retainer from (b)(6) abdomen prior to the conclusion of (b)(6) surgery on (b)(6) 2010. This failure resulted in (b)(6) requiring a subsequent surgery to remove the retainer from his abdomen. As adept-med and/or the retainer are not named as a party to the law suit, (b)(6) stated that due to client confidentiality the only information they could provide adept-med regarding this incident was a printed copy of the documents that were public record i. E. A copy of the legal filing, the fourth amended complaint at law, filed (b)(6) 2014 and two pictures of the retainer taken after its removal from (b)(6) abdomen. Adept was able to confirm the device in question was in fact a glassman viscera retainer from the pictures. The information in this 3500a was obtained from the aforementioned legal filing. (b)(6) contacted adept-med to request "a copy of any written materials pertaining to the fish which were available" at the time of the incident and to purchase a retainer. We explained the requirement for a physician's order to sell them a retainer, and sent them the requested written materials.
Patient Sequence No: 1, Text Type: N, H10
[40643699]
On (b)(6) 2010 patient (b)(6) was "taken to surgery for an exploratory laparotomy and surgical takedown of a colostomy". According to the information received from (b)(6) legal representative, a glassman viscera retainer was used in the aforementioned surgery and "left in (b)(6) abdomen at the conclusion of the surgery". "on (b)(6) 2010, (b)(6) discovered that a surgical instrument had been retained in his abdomen". (b)(6) required surgery to remove that instrument i. E. A glassman viscera retainer. At adept's request, (b)(6) legal representative supplied pictures of the retained instrument which confirmed that it was in fact a glassman viscera retainer. The glassman viscera retainer is a single use, sterile disposable device that facilitates closure of the abdominal cavity. It is removed from the patient at the conclusion of the abdominal closure. There is a "string" attached to the retainer, a ring attached to the string both of which reside outside the body during surgery to indicate that the device is present in the abdominal cavity. The ring and string were still attached to the retainer when it was removed from (b)(6) abdomen in the surgery to remove the retained surgical instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918699-2015-00001 |
| MDR Report Key | 5507327 |
| Report Source | OTHER |
| Date Received | 2015-06-10 |
| Date of Report | 2015-06-08 |
| Date of Event | 2010-02-25 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2016-03-17 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLASSMAN VISCERA RETAINER |
| Generic Name | VISCERA RETAINER/FISH |
| Product Code | GCZ |
| Date Received | 2015-06-10 |
| Model Number | 3204 |
| Catalog Number | 3204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADEPT-MED INTL., INC. |
| Manufacturer Address | 665 PLEASANT VALLEY RD DIAMOND SPRINGS CA 95619 US 95619 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-10 |