MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-30 for LAP CHOLE PACK 89-6201 manufactured by Deroyal Industries, Inc..
[78790774]
Investigation summary: an internal complaint ((b)(4)) was received indicating that the foam border around the fenestration of a drape contained within a convenience kit (finished good (b)(4)) was flaking off into the surgical site. The defective sample was returned for evaluation and received june 29, 2017. The drape contained within the finished good kit is supplied to deroyal by (b)(4). The defective sample and a supplier corrective action request have been issued to (b)(4). The investigation is incomplete at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[78790775]
The foam border around the fenestration in the lap drape was flaking off into the surgical site, which required replacing the drape. This caused a 15-minute delay along with fear that the surgical site was contaminated with foam flakes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2017-00009 |
| MDR Report Key | 6680138 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-30 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-06-30 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP CHOLE PACK |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2017-06-30 |
| Returned To Mfg | 2017-06-29 |
| Model Number | 89-6201 |
| Lot Number | 41894522 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-30 |