MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-10 for BIODESIGN HERNIA GRAFT C-SLH-8H-13X22 manufactured by Cook Biotech.
[47192618]
Date of event not provided by the complainant. Implant date indicated as early (b)(6) 2016. Explant date indicated as eleven days post-op. A review of the device history records indicated that the device was manufactured to specifications and that two devices were produced in this lot. A review of the cbi complaint database did not reveal any other complaints relating to this lot. Since a member of the clinical study staff indicated the "complication may have been related to the mesh," an mdr will be filed. However, this complaint is still under investigation. Communication attempts with the surgeon are ongoing in an effort to clarify / confirm if the biodesign hernia graft was alleged to have caused or contributed to the formation of the fistula and / or the need for intervention. A follow-up mdr will be filed if additional details are obtained.
Patient Sequence No: 1, Text Type: N, H10
[47192619]
The patient presented to the hospital for elective takedown of brooke's ileostomy and formation of a new kock pouch. In early (b)(6), the patient underwent exploratory laparotomy, lysis of adhesions, conversion of brooke end ileostomy to kock pouch, midline incisional hernia repair with biodesign hernia graft and bilateral stent placement. The defect size was 5 cm by 15 cm. Four days post-op, the jp drain in his right lower quadrant was removed. On (b)(6) 2016, the patient had a fever to 38. 5 degrees celsius (101. 3 degrees fahrenheit). Despite this he felt well. A ct scan was done which showed a fistula between kock pouch and midline incision. Ten days post-op the patient underwent a fluoroscopy drain study to further characterize the fistula. He was subsequently prepped for the operating room.
Patient Sequence No: 1, Text Type: D, B5
[48680324]
Date of event not provided by the complainant. Implant date indicated as early (b)(6) 2016. Explant date indicated as eleven days post-op. A review of the device history records indicated that the device was manufactured to specifications and that two devices were produced in this lot. A review of the cbi complaint database did not reveal any other complaints relating to this lot. Since a member of the clinical study staff indicated the "complication may have been related to the mesh," an mdr will be filed. However, this complaint is still under investigation. Communication attempts with the surgeon are ongoing in an effort to clarify / confirm if the biodesign hernia graft was alleged to have caused or contributed to the formation of the fistula and / or the need for intervention. A follow-up mdr will be filed if additional details are obtained. Update: on 06/30/2016, a representative at the study site reported that the surgeon did not believe that the biodesign hernia graft contributed to or caused the formation of the fistula. The manufacturer is still awaiting the final report of the histopathology evaluation.
Patient Sequence No: 1, Text Type: N, H10
[48680365]
The patient presented to the hospital for elective takedown of brooke's ileostomy and formation of a new kock pouch. In early march the patient underwent exploratory laparotomy, lysis of adhesions, conversion of brooke end ileostomy to kock pouch, midline incisional hernia repair with biodesign hernia graft and bilateral stent placement. The defect size was 5 cm by 15 cm. Four days post-op the jp drain in his right lower quadrant was removed. On (b)(6) 2016 the patient had a fever to 38. 5 degrees celsius (101. 3 degrees fahrenheit). Despite this he felt well. A ct scan was done which showed a fistula between kock pouch and midline incision. Ten days post-op the patient underwent a fluoroscopy drain study to further characterize the fistula. He was subsequently prepped for the or. Eleven days post-op the patient was taken back to the operating room and underwent exploratory laparotomy with excision of the partially dissolved and fragmented biodesign hernia graft and creation of a diverting loop ileostomy. Update: on 06/30/2016, a representative at the study site reported that the surgeon did not believe that the biodesign hernia graft contributed to or caused the formation of the fistula.
Patient Sequence No: 1, Text Type: D, B5
[54895769]
Implant date indicated as early (b)(6) 2016. Explant date indicated as eleven days post-op. A review of the device history records indicated that the device was manufactured to specifications and that two devices were produced in this lot. A review of the (b)(4) complaint database did not reveal any other complaints relating to this lot. Since a member of the clinical study staff indicated the "complication may have been related to the mesh," an mdr will be filed. However, this complaint is still under investigation. Communication attempts with the surgeon are ongoing in an effort to clarify / confirm if the biodesign hernia graft was alleged to have caused or contributed to the formation of the fistula and / or the need for intervention. A follow-up mdr will be filed if additional details are obtained. Update: on 06/30/2016, a representative at the study site reported that the surgeon did not believe that the biodesign hernia graft contributed to or caused the formation of the fistula. The manufacturer is still awaiting the final report of the histopathology evaluation. Update #2: in relation to the histopathology report, bacterial colonies were not noted on the hematoxylin and eosin (he) stain, but they are reportedly difficult to confirm with he stain. The results are potentially indicative of a bacterial infection. Given the nature of the original surgery performed, with the placement of the biodesign graft, and the occurrence of a fistula, infection is a probable occurrence. The biodesign hernia graft was not alleged to be the source of an infection.
Patient Sequence No: 1, Text Type: N, H10
[54895770]
The patient presented to the hospital for elective takedown of brooke's ileostomy and formation of a new kock pouch. In early (b)(6) the patient underwent exploratory laparotomy, lysis of adhesions, conversion of brooke end ileostomy to kock pouch, midline incisional hernia repair with biodesign hernia graft and bilateral stent placement. The defect size was 5 cm by 15 cm. Four days post-op the jp drain in his right lower quadrant was removed. On (b)(6) 2016 the patient had a fever to 38. 5 degrees celsius (101. 3 degrees fahrenheit). Despite this he felt well. A ct scan was done which showed a fistula between kock pouch and midline incision. Ten days post-op the patient underwent a fluoroscopy drain study to further characterize the fistula. He was subsequently prepped for the operating room. Eleven days post-op the patient was taken back to the operating room and underwent exploratory laparotomy with excision of the partially dissolved and fragmented biodesign hernia graft and creation of a diverting loop ileostomy. Update: on 06/30/2016, a representative at the study site reported that the surgeon did not believe that the biodesign hernia graft contributed to or caused the formation of the fistula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2016-00199 |
| MDR Report Key | 5718402 |
| Date Received | 2016-06-10 |
| Date of Report | 2016-07-21 |
| Date Mfgr Received | 2016-07-12 |
| Device Manufacturer Date | 2015-12-18 |
| Date Added to Maude | 2016-06-10 |
| 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 | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODESIGN HERNIA GRAFT |
| Generic Name | HERNIA GRAFT |
| Product Code | OXK |
| Date Received | 2016-06-10 |
| Catalog Number | C-SLH-8H-13X22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-10 |