MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-31 for LAP CHOLE KIT 89-6201 manufactured by Deroyal Industries, Inc..
[84998275]
Investigation summary an internal complaint (call (b)(4)) was received indicating that a lap chole pack (finished good 89-6201, lot 41912794) contained a fenestrated key drape that was flaking, allowing debris into the surgical site. The sample is reported to be available for return. However, as of the date of this report, the sample has not been received for evaluation. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The affected drape (raw material (b)(4)) was supplied to deroyal by (b)(4). A supplier corrective action request (scar) was issued august 15, 2017, and a response is due september 26, 2017. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[84998276]
The fenestrated key sheet was flaking, which led to debris in the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2017-00014 |
| MDR Report Key | 6833565 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-08-31 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-10 |
| Date Added to Maude | 2017-08-31 |
| 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 KIT |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2017-08-31 |
| Returned To Mfg | 2017-09-15 |
| Model Number | 89-6201 |
| Lot Number | 41912794 |
| 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 | 2017-08-31 |