MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-12-13 for MINSTREL (INCL. MINERVA) manufactured by Arjohuntleigh Polska Sp. Zo.o..
[4100921]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11460397]
(b)(4). Arjohuntleigh received a complaint where it was indicated that stitching inside of the loops became loose and failed during use. No injuries have been reported by the customer. When reviewing similar reportable events, we have found a number of cases with similar fault description (loop stitching inside loop failed). The trend observed for reportable complaints with this failure mode is currently considered to be low and stable. During our investigation, we were no able to find a deficiency with the lift (minstrel). No equipment functionality issues were indicated. The sling was found with loop stitching inside loop failed and was found to not have been to specification. In this case we can determine that the minstrel and the sling which work as a system were found to have not been to specification when the event took place. Test carried out during the development of the sling, and in current production on every sling manufactured, would indicate the stitching of the loops meets the mfr specification. A proper inspection of the sling should have detected the failure of the sling, when both attachments points of the red loop were broken. The sling showing signs of unstitching, should be withdrawn and replaced. From the information received no fault have been discovered before pre-use check of the sling. From the information received the sling was being used with the patient when the failure of the stitching inside loop was found. Out tests reports confirm that the sling is not likely to fail during the intended, correct use as described in the instructions for use. Therefore, we find it likely that the stitching inside the loop broke due to an excessive amount of force outside of intended use. This constitutes a use error. We find this complaint to be reportable to the competent authorities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2013-00065 |
| MDR Report Key | 3536972 |
| Report Source | 06,07 |
| Date Received | 2013-12-13 |
| Date Mfgr Received | 2013-11-12 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2013-12-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINSTREL (INCL. MINERVA) |
| Generic Name | NONE |
| Product Code | JFT |
| Date Received | 2013-12-13 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-13 |