MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-24 for NEURO PATTIE 30-054 manufactured by Carwild Corp..
[52954393]
Investigation summary: medwatch report (b)(4) was received july 26, 2016, and entered as call (b)(4). According to the medwatch report, a neuro pattie became detached from its locator string and was unable to be located. The sponge is supplied to deroyal by (b)(4). As such, a supplier corrective action request (scar) was submitted to the supplier's manufacturing facility, (b)(4). The reporting customer has been contacted regarding sample availability.
Patient Sequence No: 1, Text Type: N, H10
[52954394]
Neuro sponge was missing from the end of the attached string at completion of a surgical procedure. Room checked, surgical field searched. Special attention paid to surgical site, x-ray taken and the sponge was never located. In discussion with staff, it is reported these sponges become loose on string when they are saturated. What was the original intended procedure? L3-l5 revision, l5-s1 decompression.
Patient Sequence No: 1, Text Type: D, B5
[58373741]
Root cause: the neuro pattie is supplied to deroyal industries, inc. By (b)(4). Therefore, a supplier corrective action request (scar) was submitted to (b)(4). In its scar response, the supplier stated the reported issue could happen due to the medical staff attempting to remove the pattie by the string. In the ifu, it states, "the string is attached to the sponge for location or identification purposes only. Do not use the string to remove the sponge from the wound. " correction: in its scar response, (b)(4) stated all personnel involved (supervisor, group leader and collaborators) were notified about the reported issue for awareness during the process. Corrective action: a corrective action has not been taken. Investigation summary medwatch report (b)(4) was received july 26, 2016, and entered as (b)(4). According to the medwatch report, a neuro pattie became detached from its locator string and was unable to be located. The reporting customer returned a representative sample from the same lot for evaluation. Deroyal purchases the neuro patties from (b)(4). A scar and the sample returned by the customer were sent to (b)(4) for review. According to the scar, the supplier's investigation showed the work order was completed according to current procedure and customer requirements. Deroyal reviewed two cases of inventory. No cases from the reported lot number were available. Samples were counted to ensure proper count, pulled on, and soaked with saline then pulled on. No rejects were identified. Preventive action: a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[58373742]
Neuro sponge was missing from the end of the attached string at completion of a surgical procedure. Room checked, surgical field searched. Special attention paid to surgical site, x-ray taken and the sponge was never located. In discussion with staff, it is reported these sponges become loose on string when they are saturated. What was the original intended procedure: l3-l5 revision, l5-s1 decompression.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2016-00024 |
| MDR Report Key | 5900639 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-24 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-06-29 |
| Date Mfgr Received | 2016-07-26 |
| Date Added to Maude | 2016-08-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURO PATTIE |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2016-08-24 |
| Returned To Mfg | 2016-08-30 |
| Catalog Number | 30-054 |
| Lot Number | 15E1947 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARWILD CORP. |
| Manufacturer Address | 3 STATE PIER RD. NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-24 |